A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00468650

Collaborator

(none)

117

Enrollment

Locations

Arm

Duration (Months)

11.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to 100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: sildenafil citrate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open Label, High Dose (100mg) Rapid Titration Study, To Evaluate The Efficacy And Satisfaction Of Patrex® (Sildenafil Citrate) In Men With Erectile Dysfunction In Mexico.

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open label Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive Patrex® 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to Patrex® 100 mg PRN for the following four weeks.	Drug: sildenafil citrate Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.

Arm

Intervention/Treatment

Active Comparator: Open label

Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive Patrex® 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to Patrex® 100 mg PRN for the following four weeks.

Drug: sildenafil citrate

Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.

Outcome Measures

Primary Outcome Measures

International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) [Week 6 LOCF]
IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Secondary Outcome Measures

International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 [Week 2, Week 4 and Week 6]
IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 [Week 4 and Week 6]
IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline [Week 2, Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 [Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline [Week 2, Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 [Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline [Week 2, Week 4, and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 [Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline [Week 2, Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 [Week 4 and Week 6]
IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline [Week 2, Week 4, and Week 6]
QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.
Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 [Week 4 and Week 6]
QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline [Week 2, Week 4 and Week 6]
Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.
Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 [Week 4 and Week 6]
Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline [Week 2, Week 4, and Week 6]
Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 [Week 4 and Week 6]
Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline [Week 2, Week 4, and Week 6]
Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 [Week 4 and Week 6]
Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline [Week 2, Week 4, and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [Week 2, Week 4 and Week 6]
Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [Week 4 and Week 6]
Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented Clinical diagnosis of Erectile Dysfunction (ED) by International Index of Erectile Function (IIEF) Erectile Function (EF) Domain score less than or equal to 25.
Subjects must be in a stable relationship

Exclusion Criteria:

Subject with resting sitting hypotension (BP <90/50 mmHg) or hypertension (BP>170/110 mmHg) and orthostatic hypotension.
Subjects receiving any PDE (Phosphodiesterase)-5 inhibitors within 4 weeks prior to the date of screening.
Subjects with severe hepatic impairment, a known history of retinitis pigmentare.
Subjects with significant cardiovascular disease in the last 3 months (per medical history.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Mexico	D.f.	Mexico	11520
2	Pfizer Investigational Site	Mexico	D.f.	Mexico	11850
3	Pfizer Investigational Site	Mexico	DF	Mexico	11850
4	Pfizer Investigational Site	Mexico	Distrito Federal	Mexico	11850
5	Pfizer Investigational Site	Naucalpan	Edo. De México	Mexico	53100
6	Pfizer Investigational Site	Zapopan	Jalisco	Mexico	45040
7	Pfizer Investigational Site	Zapopan	Jalisco	Mexico	45200
8	Pfizer Investigational Site	Aguascalientes		Mexico	20000
9	Pfizer Investigational Site	Durango		Mexico	34300
10	Pfizer Investigational Site	Naucalpan Edo. De Mexico		Mexico

Sponsors and Collaborators

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

ClinicalTrials.gov Identifier:

NCT00468650

Other Study ID Numbers:

A1481251

First Posted:

May 3, 2007

Last Update Posted:

Feb 18, 2021

Last Verified:

Jan 1, 2021

Additional relevant MeSH terms:

Erectile Dysfunction

Sildenafil Citrate

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	Eligible subjects had to have at least 2 attempts at sexual intercourse during the 2 week screening phase to begin the sildenafil citrate 50mg treatment at baseline.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Period Title: Overall Study
STARTED	117
COMPLETED	110
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Overall Participants	117
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.3 (11)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	117 100%

Outcome Measures

1. Primary Outcome

Title	International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)
Description	IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.
Time Frame	Week 6 LOCF

Outcome Measure Data

Analysis Population Description
Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Mean (Standard Deviation) [score on scale]	10.96 (5.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical significance will be declared if the p-value is <0.05. Change from Baseline: Week 6 (LOCF) minus Baseline
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.96
	Confidence Interval	() 95% 10.00 to 11.93
	Parameter Dispersion	Type: Standard Deviation Value: 5.19
	Estimation Comments

2. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6
Description	IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	7.14 (5.21)
Week 4 (N=112)	10.57 (5.43)
Week 6 (N=110)	10.93 (5.26)
Week 6 Endpoint (N=112)	10.95 (5.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	7.14
	Confidence Interval	() 95% 6.17 to 8.11
	Parameter Dispersion	Type: Standard Deviation Value: 5.21
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.57
	Confidence Interval	() 95% 9.56 to 11.59
	Parameter Dispersion	Type: Standard Deviation Value: 5.43
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.93
	Confidence Interval	() 95% 9.93 to 11.92
	Parameter Dispersion	Type: Standard Deviation Value: 5.26
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.95
	Confidence Interval	() 95% 9.97 to 11.92
	Parameter Dispersion	Type: Standard Deviation Value: 5.21
	Estimation Comments

3. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2
Description	IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	3.48 (3.97)
Week 6 (N=110)	3.88 (4.38)
Week 6 LOCF (N=112)	3.86 (4.35)
Week 6 Endpoint (N=112)	3.86 (4.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.48
	Confidence Interval	() 95% 2.74 to 4.23
	Parameter Dispersion	Type: Standard Deviation Value: 3.97
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.88
	Confidence Interval	() 95% 3.05 to 4.71
	Parameter Dispersion	Type: Standard Deviation Value: 4.38
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.86
	Confidence Interval	() 95% 3.04 to 4.67
	Parameter Dispersion	Type: Standard Deviation Value: 4.35
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.86
	Confidence Interval	() 95% 3.04 to 4.67
	Parameter Dispersion	Type: Standard Deviation Value: 4.35
	Estimation Comments

4. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	1.89 (2.40)
Week 4 (N=112)	2.46 (2.32)
Week 6 (N=110)	2.59 (2.44)
Week 6 LOCF (N=113)	2.63 (2.45)
Week 6 Endpoint (N=112)	2.59 (2.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.89
	Confidence Interval	() 95% 1.45 to 2.34
	Parameter Dispersion	Type: Standard Deviation Value: 2.40
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.46
	Confidence Interval	() 95% 2.02 to 2.89
	Parameter Dispersion	Type: Standard Deviation Value: 2.32
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.59
	Confidence Interval	() 95% 2.13 to 3.05
	Parameter Dispersion	Type: Standard Deviation Value: 2.44
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.63
	Confidence Interval	() 95% 2.17 to 3.08
	Parameter Dispersion	Type: Standard Deviation Value: 2.45
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.59
	Confidence Interval	() 95% 2.14 to 3.04
	Parameter Dispersion	Type: Standard Deviation Value: 2.42
	Estimation Comments

5. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	0.61 (1.51)
Week 6 (N=110)	0.75 (1.46)
Week 6 LOCF (N=112)	0.74 (1.45)
Week 6 Endpoint (N=112)	0.74 (1.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.61
	Confidence Interval	() 95% 0.32 to 0.89
	Parameter Dispersion	Type: Standard Deviation Value: 1.51
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.75
	Confidence Interval	() 95% 0.47 to 1.02
	Parameter Dispersion	Type: Standard Deviation Value: 1.46
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.74
	Confidence Interval	() 95% 0.47 to 1.01
	Parameter Dispersion	Type: Standard Deviation Value: 1.45
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.74
	Confidence Interval	() 95% 0.47 to 1.01
	Parameter Dispersion	Type: Standard Deviation Value: 1.45
	Estimation Comments

6. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	1.43 (1.87)
Week 4 (N=112)	2.00 (1.86)
Week 6 (N=110)	2.25 (1.91)
Week 6 LOCF (N=113)	2.26 (1.94)
Week 6 Endpoint (N=112)	2.28 (1.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.43
	Confidence Interval	() 95% 1.09 to 1.78
	Parameter Dispersion	Type: Standard Deviation Value: 1.87
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.00
	Confidence Interval	() 95% 1.65 to 2.35
	Parameter Dispersion	Type: Standard Deviation Value: 1.86
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.25
	Confidence Interval	() 95% 1.89 to 2.62
	Parameter Dispersion	Type: Standard Deviation Value: 1.91
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.26
	Confidence Interval	() 95% 1.90 to 2.62
	Parameter Dispersion	Type: Standard Deviation Value: 1.94
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.28
	Confidence Interval	() 95% 1.91 to 2.64
	Parameter Dispersion	Type: Standard Deviation Value: 1.93
	Estimation Comments

7. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	0.55 (1.41)
Week 6 (N=110)	0.81 (1.47)
Week 6 LOCF (N=112)	0.83 (1.49)
Week 6 Endpoint (N=112)	0.83 (1.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.55
	Confidence Interval	() 95% 0.29 to 0.82
	Parameter Dispersion	Type: Standard Deviation Value: 1.41
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.81
	Confidence Interval	() 95% 0.53 to 1.09
	Parameter Dispersion	Type: Standard Deviation Value: 1.47
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.83
	Confidence Interval	() 95% 0.55 to 1.11
	Parameter Dispersion	Type: Standard Deviation Value: 1.49
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.83
	Confidence Interval	() 95% 0.55 to 1.11
	Parameter Dispersion	Type: Standard Deviation Value: 1.49
	Estimation Comments

8. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.
Time Frame	Week 2, Week 4, and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	3.18 (2.42)
Week 4 (N=112)	4.38 (2.39)
Week 6 (N=110)	4.73 (2.53)
Week 6 LOCF (N=113)	4.70 (2.52)
Week 6 Endpoint (N=112)	4.72 (2.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.18
	Confidence Interval	() 95% 2.73 to 3.63
	Parameter Dispersion	Type: Standard Deviation Value: 2.42
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.38
	Confidence Interval	() 95% 3.94 to 4.83
	Parameter Dispersion	Type: Standard Deviation Value: 2.39
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.73
	Confidence Interval	() 95% 4.25 to 5.21
	Parameter Dispersion	Type: Standard Deviation Value: 2.53
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.70
	Confidence Interval	() 95% 4.23 to 5.17
	Parameter Dispersion	Type: Standard Deviation Value: 2.52
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.72
	Confidence Interval	() 95% 4.25 to 5.19
	Parameter Dispersion	Type: Standard Deviation Value: 2.52
	Estimation Comments

9. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	1.20 (2.10)
Week 6 (N=110)	1.54 (2.20)
Week 6 LOCF (N=112)	1.54 (2.19)
Week 6 Endpoint (N=112)	1.54 (2.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.20
	Confidence Interval	() 95% 0.80 to 1.59
	Parameter Dispersion	Type: Standard Deviation Value: 2.10
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.54
	Confidence Interval	() 95% 1.12 to 1.95
	Parameter Dispersion	Type: Standard Deviation Value: 2.20
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.54
	Confidence Interval	() 95% 1.13 to 1.95
	Parameter Dispersion	Type: Standard Deviation Value: 2.19
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.54
	Confidence Interval	() 95% 1.13 to 1.95
	Parameter Dispersion	Type: Standard Deviation Value: 2.19
	Estimation Comments

10. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	2.73 (2.38)
Week 4 (N=112)	3.67 (2.49)
Week 6 (N=110)	3.92 (2.52)
Week 6 LOCF (N=113)	3.91 (2.53)
Week 6 Endpoint (N=112)	3.89 (2.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.73
	Confidence Interval	() 95% 2.28 to 3.17
	Parameter Dispersion	Type: Standard Deviation Value: 2.38
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.67
	Confidence Interval	() 95% 3.20 to 4.14
	Parameter Dispersion	Type: Standard Deviation Value: 2.49
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.92
	Confidence Interval	() 95% 3.44 to 4.40
	Parameter Dispersion	Type: Standard Deviation Value: 2.52
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.91
	Confidence Interval	() 95% 3.44 to 4.38
	Parameter Dispersion	Type: Standard Deviation Value: 2.53
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.89
	Confidence Interval	() 95% 3.42 to 4.37
	Parameter Dispersion	Type: Standard Deviation Value: 2.53
	Estimation Comments

11. Secondary Outcome

Title	International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2
Description	IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	0.97 (1.88)
Week 6 (N=110)	1.21 (1.92)
Week 6 LOCF (N=112)	1.20 (1.90)
Week 6 Endpoint (N=112)	1.20 (1.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.97
	Confidence Interval	() 95% 0.62 to 1.32
	Parameter Dispersion	Type: Standard Deviation Value: 1.88
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.21
	Confidence Interval	() 95% 0.85 to 1.57
	Parameter Dispersion	Type: Standard Deviation Value: 1.92
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.20
	Confidence Interval	() 95% 0.84 to 1.55
	Parameter Dispersion	Type: Standard Deviation Value: 1.90
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.20
	Confidence Interval	() 95% 0.84 to 1.55
	Parameter Dispersion	Type: Standard Deviation Value: 1.90
	Estimation Comments

12. Secondary Outcome

Title	Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline
Description	QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.
Time Frame	Week 2, Week 4, and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	32.71 (25.36)
Week 4 (N=112)	46.21 (26.27)
Week 6 (N=110)	45.53 (26.96)
Week 6 LOCF (N=113)	45.28 (27.01)
Week 6 Endpoint (N=112)	45.05 (27.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	32.71
	Confidence Interval	() 95% 27.98 to 37.43
	Parameter Dispersion	Type: Standard Deviation Value: 25.36
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	46.21
	Confidence Interval	() 95% 41.29 to 51.12
	Parameter Dispersion	Type: Standard Deviation Value: 26.27
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	45.53
	Confidence Interval	() 95% 40.44 to 50.63
	Parameter Dispersion	Type: Standard Deviation Value: 26.96
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	45.28
	Confidence Interval	() 95% 40.25 to 50.31
	Parameter Dispersion	Type: Standard Deviation Value: 27.01
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	45.05
	Confidence Interval	() 95% 39.99 to 50.11
	Parameter Dispersion	Type: Standard Deviation Value: 27.02
	Estimation Comments

13. Secondary Outcome

Title	Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2
Description	QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 4 (N=112)	13.84 (21.10)
Week 6 (N=110)	13.07 (24.25)
Week 6 LOCF (N=112)	12.69 (24.26)
Week 6 Endpoint (N=112)	12.69 (24.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.84
	Confidence Interval	() 95% 9.89 to 17.79
	Parameter Dispersion	Type: Standard Deviation Value: 21.10
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.07
	Confidence Interval	() 95% 8.49 to 17.65
	Parameter Dispersion	Type: Standard Deviation Value: 24.25
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.69
	Confidence Interval	() 95% 8.14 to 17.23
	Parameter Dispersion	Type: Standard Deviation Value: 24.26
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.69
	Confidence Interval	() 95% 8.14 to 17.23
	Parameter Dispersion	Type: Standard Deviation Value: 24.26
	Estimation Comments

14. Secondary Outcome

Title	Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline
Description	Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	5.41 (4.40)
Week 4 (N=112)	8.85 (4.96)
Week 6 (N=110)	9.21 (5.19)
Week 6 LOCF (N=113)	9.28 (5.14)
Week 6 Endpoint (N=112)	9.25 (5.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.41
	Confidence Interval	() 95% 4.59 to 6.23
	Parameter Dispersion	Type: Standard Deviation Value: 4.40
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	8.85
	Confidence Interval	() 95% 7.92 to 9.78
	Parameter Dispersion	Type: Standard Deviation Value: 4.96
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.21
	Confidence Interval	() 95% 8.23 to 10.19
	Parameter Dispersion	Type: Standard Deviation Value: 5.19
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.28
	Confidence Interval	() 95% 8.32 to 10.24
	Parameter Dispersion	Type: Standard Deviation Value: 5.14
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.25
	Confidence Interval	() 95% 8.28 to 10.22
	Parameter Dispersion	Type: Standard Deviation Value: 5.15
	Estimation Comments

15. Secondary Outcome

Title	Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2
Description	Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	3.51 (3.89)
Week 6 (N=110)	3.91 (4.41)
Week 6 LOCF (N=112)	3.91 (4.38)
Week 6 Endpoint (N=112)	3.91 (4.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.51
	Confidence Interval	() 95% 2.78 to 4.24
	Parameter Dispersion	Type: Standard Deviation Value: 3.89
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.91
	Confidence Interval	() 95% 3.08 to 4.74
	Parameter Dispersion	Type: Standard Deviation Value: 4.41
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.91
	Confidence Interval	() 95% 3.09 to 4.73
	Parameter Dispersion	Type: Standard Deviation Value: 4.38
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.91
	Confidence Interval	() 95% 3.09 to 4.73
	Parameter Dispersion	Type: Standard Deviation Value: 4.38
	Estimation Comments

16. Secondary Outcome

Title	Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline
Description	Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome
Time Frame	Week 2, Week 4, and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Week 2 (N=113)	6.68 (4.86)
Week 4 (N=112)	9.94 (5.21)
Week 6 (N=108)	10.59 (5.08)
Week 6 LOCF (N=111)	10.63 (5.03)
Week 6 Endpoint (N=110)	10.64 (5.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	6.68
	Confidence Interval	() 95% 5.77 to 7.59
	Parameter Dispersion	Type: Standard Deviation Value: 4.86
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.94
	Confidence Interval	() 95% 8.96 to 10.91
	Parameter Dispersion	Type: Standard Deviation Value: 5.21
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.59
	Confidence Interval	() 95% 9.62 to 11.56
	Parameter Dispersion	Type: Standard Deviation Value: 5.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.63
	Confidence Interval	() 95% 9.68 to 11.58
	Parameter Dispersion	Type: Standard Deviation Value: 5.03
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.64
	Confidence Interval	() 95% 9.68 to 11.59
	Parameter Dispersion	Type: Standard Deviation Value: 5.06
	Estimation Comments

17. Secondary Outcome

Title	Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2
Description	Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	3.29 (4.10)
Week 6 (N=108)	4.03 (5.09)
Week 6 LOCF (N=110)	4.01 (5.04)
Week 6 Endpoint (N=110)	4.01 (5.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.29
	Confidence Interval	() 95% 2.52 to 4.05
	Parameter Dispersion	Type: Standard Deviation Value: 4.10
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.03
	Confidence Interval	() 95% 3.06 to 5.00
	Parameter Dispersion	Type: Standard Deviation Value: 5.09
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.01
	Confidence Interval	() 95% 3.06 to 4.96
	Parameter Dispersion	Type: Standard Deviation Value: 5.04
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.01
	Confidence Interval	() 95% 3.06 to 4.96
	Parameter Dispersion	Type: Standard Deviation Value: 5.04
	Estimation Comments

18. Secondary Outcome

Title	Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline
Description	Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.
Time Frame	Week 2, Week 4, and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 2 (N=112)	2.79 (2.44)
Week 4 (N=111)	4.23 (2.56)
Week 6 (N=108)	4.74 (2.84)
Week 6 LOCF (N=111)	4.78 (2.81)
Week 6 Endpoint (N=110)	4.76 (2.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.79
	Confidence Interval	() 95% 2.33 to 3.24
	Parameter Dispersion	Type: Standard Deviation Value: 2.44
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.23
	Confidence Interval	() 95% 3.74 to 4.71
	Parameter Dispersion	Type: Standard Deviation Value: 2.56
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.74
	Confidence Interval	() 95% 4.20 to 5.28
	Parameter Dispersion	Type: Standard Deviation Value: 2.84
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.78
	Confidence Interval	() 95% 4.25 to 5.31
	Parameter Dispersion	Type: Standard Deviation Value: 2.81
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.76
	Confidence Interval	() 95% 4.23 to 5.30
	Parameter Dispersion	Type: Standard Deviation Value: 2.82
	Estimation Comments

19. Secondary Outcome

Title	Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2
Description	Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=112)	1.49 (1.91)
Week 6 (N=109)	1.96 (2.08)
Week 6 LOCF (N=111)	1.98 (2.07)
Week 6 Endpoint (N=111)	1.98 (2.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.49
	Confidence Interval	() 95% 1.13 to 1.85
	Parameter Dispersion	Type: Standard Deviation Value: 1.91
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.96
	Confidence Interval	() 95% 1.57 to 2.36
	Parameter Dispersion	Type: Standard Deviation Value: 2.08
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.98
	Confidence Interval	() 95% 1.59 to 2.37
	Parameter Dispersion	Type: Standard Deviation Value: 2.07
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.98
	Confidence Interval	() 95% 1.59 to 2.37
	Parameter Dispersion	Type: Standard Deviation Value: 2.07
	Estimation Comments

20. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	110
Question 1 (Week 2) N=110	8.84 (28.70)
Question 1 (Week 4) N=108	10.18 (27.51)
Question 1 (Week 6) N=105	12.29 (28.88)
Question 1 (Week 6 LOCF) N=110	11.96 (28.33)
Question 1 (Week 6 Endpoint) N=108	11.95 (28.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	8.84
	Confidence Interval	() 95% 3.42 to 14.26
	Parameter Dispersion	Type: Standard Deviation Value: 28.70
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.18
	Confidence Interval	() 95% 4.93 to 15.43
	Parameter Dispersion	Type: Standard Deviation Value: 27.51
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.29
	Confidence Interval	() 95% 6.70 to 17.88
	Parameter Dispersion	Type: Standard Deviation Value: 28.88
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	11.96
	Confidence Interval	() 95% 6.61 to 17.32
	Parameter Dispersion	Type: Standard Deviation Value: 28.33
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	11.95
	Confidence Interval	() 95% 6.51 to 17.40
	Parameter Dispersion	Type: Standard Deviation Value: 28.55
	Estimation Comments

21. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	113
Question 1 (Week 4) N=111	1.37 (14.85)
Question 1 (Week 6) N=108	3.12 (14.26)
Question 1 (Week 6 LOCF) N=113	2.98 (13.95)
Question 1 (Week 6 Endpoint) N=111	3.04 (14.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3324
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.37
	Confidence Interval	() 95% -1.42 to 4.17
	Parameter Dispersion	Type: Standard Deviation Value: 14.85
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0249
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.12
	Confidence Interval	() 95% 0.40 to 5.84
	Parameter Dispersion	Type: Standard Deviation Value: 14.26
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0249
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.98
	Confidence Interval	() 95% 0.37 to 5.58
	Parameter Dispersion	Type: Standard Deviation Value: 13.95
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0249
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.04
	Confidence Interval	() 95% 0.39 to 5.68
	Parameter Dispersion	Type: Standard Deviation Value: 14.07
	Estimation Comments

22. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	102
Question 2 (Week 2) N=102	15.37 (30.51)
Question 2 (Week 4) N=100	17.15 (32.22)
Question 2 (Week 6) N=97	18.22 (32.44)
Question 2 (Week 6 LOCF) N=102	17.33 (31.87)
Question 2 (Week 6 Endpoint) N=100	17.68 (32.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	15.37
	Confidence Interval	() 95% 9.38 to 21.36
	Parameter Dispersion	Type: Standard Deviation Value: 30.51
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	17.15
	Confidence Interval	() 95% 10.76 to 23.55
	Parameter Dispersion	Type: Standard Deviation Value: 32.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	18.22
	Confidence Interval	() 95% 11.68 to 24.76
	Parameter Dispersion	Type: Standard Deviation Value: 32.44
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	17.33
	Confidence Interval	() 95% 11.07 to 23.59
	Parameter Dispersion	Type: Standard Deviation Value: 31.87
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	17.68
	Confidence Interval	() 95% 11.31 to 24.04
	Parameter Dispersion	Type: Standard Deviation Value: 32.10
	Estimation Comments

23. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Question 2 (Week 4) N=110	1.46 (9.41)
Question 2 (Week 6) N=107	1.18 (12.33)
Question 2 (Week 6 LOCF) N=112	1.13 (12.05)
Question 2 (Week 6 Endpoint) N=110	1.15 (12.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1061
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.46
	Confidence Interval	() 95% -0.32 to 3.24
	Parameter Dispersion	Type: Standard Deviation Value: 9.41
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3237
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.18
	Confidence Interval	() 95% -1.18 to 3.54
	Parameter Dispersion	Type: Standard Deviation Value: 12.33
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3236
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.13
	Confidence Interval	() 95% -1.13 to 3.38
	Parameter Dispersion	Type: Standard Deviation Value: 12.05
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3236
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.15
	Confidence Interval	() 95% -1.15 to 3.45
	Parameter Dispersion	Type: Standard Deviation Value: 12.16
	Estimation Comments

24. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	102
Question 3 (Week 2) N=102	56.96 (38.93)
Question 3 (Week 4) N=100	70.78 (35.46)
Question 3 (Week 6) N=97	71.23 (35.79)
Question 3 (Week 6 LOCF) N=102	72.15 (35.41)
Question 3 (Week 6 Endpoint) N=100	71.60 (35.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	56.96
	Confidence Interval	() 95% 49.31 to 64.60
	Parameter Dispersion	Type: Standard Deviation Value: 38.93
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	70.78
	Confidence Interval	() 95% 63.74 to 77.81
	Parameter Dispersion	Type: Standard Deviation Value: 35.46
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	71.23
	Confidence Interval	() 95% 64.02 to 78.45
	Parameter Dispersion	Type: Standard Deviation Value: 35.79
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	72.15
	Confidence Interval	() 95% 65.20 to 79.11
	Parameter Dispersion	Type: Standard Deviation Value: 35.41
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	71.60
	Confidence Interval	() 95% 64.54 to 78.65
	Parameter Dispersion	Type: Standard Deviation Value: 35.55
	Estimation Comments

25. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Question 3 (Week 4) N=110	13.56 (30.89)
Question 3 (Week 6) N=107	14.25 (31.31)
Question 3 (Week 6 LOCF) N=112	14.51 (31.77)
Question 3 (Week 6 Endpoint) N=110	14.77 (32.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.56
	Confidence Interval	() 95% 7.72 to 19.40
	Parameter Dispersion	Type: Standard Deviation Value: 30.89
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.25
	Confidence Interval	() 95% 8.25 to 20.25
	Parameter Dispersion	Type: Standard Deviation Value: 31.31
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.51
	Confidence Interval	() 95% 8.56 to 20.46
	Parameter Dispersion	Type: Standard Deviation Value: 31.77
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.77
	Confidence Interval	() 95% 8.72 to 20.82
	Parameter Dispersion	Type: Standard Deviation Value: 32.00
	Estimation Comments

26. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	102
Question 4 (Week 2) N=102	58.58 (41.24)
Question 4 (Week 4) N=100	76.29 (37.21)
Question 4(Week 6) N=97	77.69 (37.26)
Question 4 (Week 6 LOCF) N=102	78.79 (36.65)
Question 4 (Week 6 Endpoint) N=100	78.36 (36.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	58.58
	Confidence Interval	() 95% 50.48 to 66.68
	Parameter Dispersion	Type: Standard Deviation Value: 41.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	76.29
	Confidence Interval	() 95% 68.90 to 83.67
	Parameter Dispersion	Type: Standard Deviation Value: 37.21
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	77.69
	Confidence Interval	() 95% 70.18 to 85.21
	Parameter Dispersion	Type: Standard Deviation Value: 37.26
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	78.79
	Confidence Interval	() 95% 71.59 to 85.99
	Parameter Dispersion	Type: Standard Deviation Value: 36.65
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	78.36
	Confidence Interval	() 95% 71.04 to 85.68
	Parameter Dispersion	Type: Standard Deviation Value: 36.89
	Estimation Comments

27. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Question 4 (Week 4) N=110	17.90 (36.63)
Question 4 (Week 6) N=107	19.50 (36.84)
Question 4 (Week 6 LOCF) N=112	19.52 (36.99)
Question 4 (Week 6 Endpoint) N=110	19.88 (37.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	17.90
	Confidence Interval	() 95% 10.98 to 24.83
	Parameter Dispersion	Type: Standard Deviation Value: 36.63
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	19.50
	Confidence Interval	() 95% 12.44 to 26.56
	Parameter Dispersion	Type: Standard Deviation Value: 36.84
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	19.52
	Confidence Interval	() 95% 12.59 to 26.45
	Parameter Dispersion	Type: Standard Deviation Value: 36.99
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	19.88
	Confidence Interval	() 95% 12.84 to 26.91
	Parameter Dispersion	Type: Standard Deviation Value: 37.23
	Estimation Comments

28. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	102
Question 5 (Week 2) N=101	57.34 (42.60)
Question 5 (Week 4) N=100	70.72 (40.30)
Question 5 (Week 6) N=97	70.63 (40.78)
Question 5 (Week 6 LOCF) N=102	72.07 (40.27)
Question 5 (Week 6 Endpoint) N=100	71.51 (40.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	57.34
	Confidence Interval	() 95% 48.93 to 65.75
	Parameter Dispersion	Type: Standard Deviation Value: 42.60
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	70.72
	Confidence Interval	() 95% 62.72 to 78.71
	Parameter Dispersion	Type: Standard Deviation Value: 40.30
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	70.63
	Confidence Interval	() 95% 62.41 to 78.85
	Parameter Dispersion	Type: Standard Deviation Value: 40.78
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	72.07
	Confidence Interval	() 95% 64.16 to 79.98
	Parameter Dispersion	Type: Standard Deviation Value: 40.27
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	71.51
	Confidence Interval	() 95% 63.48 to 79.55
	Parameter Dispersion	Type: Standard Deviation Value: 40.48
	Estimation Comments

29. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	111
Question 5 (Week 4) N=109	13.10 (29.11)
Question 5 (Week 6) N=106	14.11 (32.53)
Question 5 (Week 6 LOCF) N=111	13.47 (31.92)
Question 5 (Week 6 Endpoint) N=109	13.72 (32.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.10
	Confidence Interval	() 95% 7.58 to 18.63
	Parameter Dispersion	Type: Standard Deviation Value: 29.11
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.11
	Confidence Interval	() 95% 7.84 to 20.37
	Parameter Dispersion	Type: Standard Deviation Value: 32.53
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.47
	Confidence Interval	() 95% 7.47 to 19.47
	Parameter Dispersion	Type: Standard Deviation Value: 31.92
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.72
	Confidence Interval	() 95% 7.61 to 19.82
	Parameter Dispersion	Type: Standard Deviation Value: 32.16
	Estimation Comments

30. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)
Time Frame	Week 2, Week 4, and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	102
Week 2 (N=102)	56.96 (38.93)
Week 4 (N=100)	70.78 (35.46)
Week 6 (N=97)	71.23 (35.79)
Week 6 LOCF (N=102)	72.15 (35.41)
Week 6 Endpoint (N=100)	71.60 (35.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus Baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	56.96
	Confidence Interval	() 95% 49.31 to 64.60
	Parameter Dispersion	Type: Standard Deviation Value: 38.93
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	70.78
	Confidence Interval	() 95% 63.74 to 77.81
	Parameter Dispersion	Type: Standard Deviation Value: 35.46
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	71.23
	Confidence Interval	() 95% 64.02 to 78.45
	Parameter Dispersion	Type: Standard Deviation Value: 35.79
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	72.15
	Confidence Interval	() 95% 65.20 to 79.11
	Parameter Dispersion	Type: Standard Deviation Value: 35.41
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	71.60
	Confidence Interval	() 95% 64.54 to 78.65
	Parameter Dispersion	Type: Standard Deviation Value: 35.55
	Estimation Comments

31. Secondary Outcome

Title	Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Week 4 (N=110)	13.56 (30.89)
Week 6 (N=107)	14.25 (31.31)
Week 6 LOCF (N=112)	14.51 (31.77)
Week 6 Endpoint (N=110)	14.77 (32.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.56
	Confidence Interval	() 95% 7.72 to 19.40
	Parameter Dispersion	Type: Standard Deviation Value: 30.89
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.25
	Confidence Interval	() 95% 8.25 to 20.25
	Parameter Dispersion	Type: Standard Deviation Value: 31.31
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.51
	Confidence Interval	() 95% 8.56 to 20.46
	Parameter Dispersion	Type: Standard Deviation Value: 31.77
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.77
	Confidence Interval	() 95% 8.72 to 20.82
	Parameter Dispersion	Type: Standard Deviation Value: 32.00
	Estimation Comments

32. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	103
Grade 1 (Week 2) N=103	-12.58 (37.77)
Grade 1 (Week 4) N=101	-20.55 (35.04)
Grade 1 (Week 6) N=98	-22.53 (36.64)
Grade 1 (Week 6 LOCF) N=103	-21.44 (36.06)
Grade 1 (Week 6 Endpoint) N=101	-21.86 (36.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0010
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.58
	Confidence Interval	() 95% -19.96 to -5.20
	Parameter Dispersion	Type: Standard Deviation Value: 37.77
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-20.55
	Confidence Interval	() 95% -27.47 to -13.64
	Parameter Dispersion	Type: Standard Deviation Value: 35.04
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-22.53
	Confidence Interval	() 95% -29.88 to -15.18
	Parameter Dispersion	Type: Standard Deviation Value: 36.64
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-21.44
	Confidence Interval	() 95% -28.49 to -14.39
	Parameter Dispersion	Type: Standard Deviation Value: 36.06
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-21.86
	Confidence Interval	() 95% -29.03 to -14.70
	Parameter Dispersion	Type: Standard Deviation Value: 36.29
	Estimation Comments

33. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Grade 1 (Week 4) N=110	-6.79 (22.58)
Grade 1 (Week 6) N=107	-6.85 (23.02)
Grade 1 (Week 6 LOCF) N=112	-7.43 (24.20)
Grade 1 (Week 6 Endpoint) N=110	-7.57 (24.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0021
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.79
	Confidence Interval	() 95% -11.06 to -2.52
	Parameter Dispersion	Type: Standard Deviation Value: 22.58
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0027
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.85
	Confidence Interval	() 95% -11.26 to -2.43
	Parameter Dispersion	Type: Standard Deviation Value: 23.02
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0015
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.43
	Confidence Interval	() 95% -11.97 to -2.90
	Parameter Dispersion	Type: Standard Deviation Value: 24.20
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0015
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.57
	Confidence Interval	() 95% -12.18 to -2.96
	Parameter Dispersion	Type: Standard Deviation Value: 24.40
	Estimation Comments

34. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	103
Grade 2 (Week 2) N=103	-9.87 (34.44)
Grade 2 (Week 4) N=101	-11.74 (32.80)
Grade 2 (Week 6) N=98	-12.78 (33.56)
Grade 2 (Week 6 LOCF) N=103	-13.13 (33.94)
Grade 2 (Week 6 Endpoint) N=101	-12.40 (33.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0045
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.87
	Confidence Interval	() 95% -16.60 to -3.14
	Parameter Dispersion	Type: Standard Deviation Value: 34.44
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.74
	Confidence Interval	() 95% -18.22 to -5.27
	Parameter Dispersion	Type: Standard Deviation Value: 32.80
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.78
	Confidence Interval	() 95% -19.51 to -6.05
	Parameter Dispersion	Type: Standard Deviation Value: 33.56
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-13.13
	Confidence Interval	() 95% -19.76 to -6.50
	Parameter Dispersion	Type: Standard Deviation Value: 33.94
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.40
	Confidence Interval	() 95% -18.94 to -5.86
	Parameter Dispersion	Type: Standard Deviation Value: 33.13
	Estimation Comments

35. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Grade 2 (Week 4) N=110	-2.39 (22.00)
Grade 2 (Week 6) N=107	-1.91 (20.73)
Grade 2 (Week 6 LOCF) N=112	-2.71 (22.28)
Grade 2 (Week 6 Endpoint) N=110	-2.76 (22.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2567
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.39
	Confidence Interval	() 95% -6.55 to 1.77
	Parameter Dispersion	Type: Standard Deviation Value: 22.00
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3435
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.91
	Confidence Interval	() 95% -5.88 to 2.07
	Parameter Dispersion	Type: Standard Deviation Value: 20.73
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2000
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.71
	Confidence Interval	() 95% -6.89 to 1.46
	Parameter Dispersion	Type: Standard Deviation Value: 22.28
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2000
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.76
	Confidence Interval	() 95% -7.01 to 1.48
	Parameter Dispersion	Type: Standard Deviation Value: 22.48
	Estimation Comments

36. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	103
Grade 3 (Week 2) N=103	-10.82 (56.75)
Grade 3 (Week 4) N=101	-29.16 (59.81)
Grade 3 (Week 6) N=98	-30.79 (60.90)
Grade 3 (Week 6 LOCF) N=103	-30.27 (61.70)
Grade 3 (Week 6 Endpoint) N=101	-30.87 (60.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0558
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.82
	Confidence Interval	() 95% -21.91 to 0.27
	Parameter Dispersion	Type: Standard Deviation Value: 56.75
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-29.16
	Confidence Interval	() 95% -40.96 to -17.35
	Parameter Dispersion	Type: Standard Deviation Value: 59.81
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-30.79
	Confidence Interval	() 95% -43.00 to -18.58
	Parameter Dispersion	Type: Standard Deviation Value: 60.90
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-30.27
	Confidence Interval	() 95% -42.33 to -18.21
	Parameter Dispersion	Type: Standard Deviation Value: 61.70
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-30.87
	Confidence Interval	() 95% -42.82 to -18.92
	Parameter Dispersion	Type: Standard Deviation Value: 60.54
	Estimation Comments

37. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Grade 1 (Week 4) N=110	-18.36 (46.03)
Grade 1 (Week 6) N=107	-22.16 (45.24)
Grade 1 (Week 6 LOCF) N=112	-20.28 (45.86)
Grade 1 (Week 6 Endpoint) N=110	-20.65 (46.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-18.36
	Confidence Interval	() 95% -27.05 to -9.66
	Parameter Dispersion	Type: Standard Deviation Value: 46.03
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-22.16
	Confidence Interval	() 95% -30.84 to -13.49
	Parameter Dispersion	Type: Standard Deviation Value: 45.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-20.28
	Confidence Interval	() 95% -28.87 to -11.69
	Parameter Dispersion	Type: Standard Deviation Value: 45.86
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-20.65
	Confidence Interval	() 95% -29.38 to -11.92
	Parameter Dispersion	Type: Standard Deviation Value: 46.20
	Estimation Comments

38. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	103
Grade 4 (Week 2) N=103	33.27 (41.43)
Grade 4 (Week 4) N=101	61.45 (44.77)
Grade 4 (Week 6) N=98	66.10 (45.15)
Grade 4 (Week 6 LOCF) N=103	64.84 (45.70)
Grade 4 (Week 6 Endpoint) N=101	65.13 (45.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	33.27
	Confidence Interval	() 95% 25.17 to 41.36
	Parameter Dispersion	Type: Standard Deviation Value: 41.43
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	61.45
	Confidence Interval	() 95% 52.61 to 70.29
	Parameter Dispersion	Type: Standard Deviation Value: 44.77
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	66.10
	Confidence Interval	() 95% 57.05 to 75.16
	Parameter Dispersion	Type: Standard Deviation Value: 45.15
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	64.84
	Confidence Interval	() 95% 55.91 to 73.77
	Parameter Dispersion	Type: Standard Deviation Value: 45.70
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	65.13
	Confidence Interval	() 95% 56.14 to 74.12
	Parameter Dispersion	Type: Standard Deviation Value: 45.56
	Estimation Comments

39. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	112
Grade 4 (Week 4) N=110	27.53 (40.19)
Grade 4 (Week 6) N=107	30.92 (41.90)
Grade 4 (Week 6 LOCF) N=112	30.43 (41.88)
Grade 4 (Week 6 Endpoint) N=110	30.98 (42.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	27.53
	Confidence Interval	() 95% 19.94 to 35.13
	Parameter Dispersion	Type: Standard Deviation Value: 40.19
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	30.92
	Confidence Interval	() 95% 22.89 to 38.95
	Parameter Dispersion	Type: Standard Deviation Value: 41.90
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	30.43
	Confidence Interval	() 95% 22.59 to 38.27
	Parameter Dispersion	Type: Standard Deviation Value: 41.88
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	30.98
	Confidence Interval	() 95% 23.04 to 38.93
	Parameter Dispersion	Type: Standard Deviation Value: 42.06
	Estimation Comments

40. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
Description	Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 2, Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	103
Grade 3 or 4 (Week 2) N=103	22.45 (46.10)
Grade 3 or 4 (Week 4) N=101	32.30 (42.15)
Grade 3 or 4 (Week 6) N=98	35.31 (43.52)
Grade 3 or 4 (Week 6 LOCF) N=103	34.57 (43.48)
Grade 3 or 4 (Week 6 Endpoint) N=101	34.26 (43.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 2 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	22.45
	Confidence Interval	() 95% 13.44 to 31.46
	Parameter Dispersion	Type: Standard Deviation Value: 46.10
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	32.30
	Confidence Interval	() 95% 23.97 to 40.62
	Parameter Dispersion	Type: Standard Deviation Value: 42.15
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	35.31
	Confidence Interval	() 95% 26.59 to 44.04
	Parameter Dispersion	Type: Standard Deviation Value: 43.52
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	34.57
	Confidence Interval	() 95% 26.07 to 43.07
	Parameter Dispersion	Type: Standard Deviation Value: 43.48
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	34.26
	Confidence Interval	() 95% 25.72 to 42.81
	Parameter Dispersion	Type: Standard Deviation Value: 43.29
	Estimation Comments

41. Secondary Outcome

Title	Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
Description	Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)
Time Frame	Week 4 and Week 6

Outcome Measure Data

Analysis Population Description
MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Measure Participants	110
Grade 3 or 4 (Week 4) N=110	9.18 (29.45)
Grade 3 or 4 (Week 6) N=107	8.75 (29.26)
Grade 3 or 4 (Week 6 LOCF ) N=112	10.15 (31.11)
Grade 3 or 4 (Week 6 Endpoint ) N=110	10.33 (31.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 4 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0014
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.18
	Confidence Interval	() 95% 3.61 to 14.74
	Parameter Dispersion	Type: Standard Deviation Value: 29.45
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0025
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	8.75
	Confidence Interval	() 95% 3.15 to 14.36
	Parameter Dispersion	Type: Standard Deviation Value: 29.26
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 LOCF minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.15
	Confidence Interval	() 95% 4.32 to 15.97
	Parameter Dispersion	Type: Standard Deviation Value: 31.11
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Open Label Sildenafil Citrate
	Comments	Week 6 Endpoint minus Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05
	Method	t-test, 2 sided
	Comments	single sample t-test

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.33
	Confidence Interval	() 95% 4.41 to 16.26
	Parameter Dispersion	Type: Standard Deviation Value: 31.36
	Estimation Comments

Adverse Events

	Open Label Sildenafil Citrate
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Open Label Sildenafil Citrate
Arm/Group Description	Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Open Label Sildenafil Citrate
	Affected / at Risk (%)	# Events
Total	0/117 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Sildenafil Citrate
	Affected / at Risk (%)	# Events
Total	33/ (NaN)
Gastrointestinal disorders
Gastritis	3/117 (2.6%)
Nervous system disorders
Headache	18/117 (15.4%)
Respiratory, thoracic and mediastinal disorders
Nasal Congestion	3/117 (2.6%)
Vascular disorders
Hot Flush	10/117 (8.5%)
Flushing	3/117 (2.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.govCallCenter@pfizer.com

Responsible Party:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

ClinicalTrials.gov Identifier:

NCT00468650

Other Study ID Numbers:

A1481251

First Posted:

May 3, 2007

Last Update Posted:

Feb 18, 2021

Last Verified:

Jan 1, 2021