Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00301262

Collaborator

Pfizer (Industry)

183

Enrollment

Locations

Duration (Months)

6.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: Viagra (Sildenafil citrate)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) [Week 8]
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).

Secondary Outcome Measures

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index [Week 8, Week 14]
Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score [Week 8]
adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Patient Reported Erectile Function Assessment (PREFA) Total Score [Week 8, Week 14]
PREFA Total Score: 8 = worst, 32 = best.
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function [Week 8]
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function [Week 8]
adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire [Week 8]
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [Week 8]
adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [Week 8]
adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function [Week 8, Week 14]
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function [Week 8, Week 14]
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire [Week 8, Week 14]
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [Week 8, Week 14]
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [Week 8, Week 14]
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score [Week 8]
adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Erectile Distress Scale (EDS) Total Score [Week 8, Week 14]
Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score [Week 8]
adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Quality of Erection Questionnaire (QEQ) Total Score [Week 8, Week 14]
QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) [Week 8, Week 14]
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) [Week 8, Week 14]
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) [Week 8, Week 14]
GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Percentage of Occasions of Successful Intercourse (Event Log) [Baseline to Week 8]
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) [Baseline to Week 8]
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Percentage of Occasions of Successful Intercourse (Event Log) [Week 8 to Week 14]
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Percentage of Occasions of Ejaculation and/or Orgasm Event Log [Week 8 to Week 14]
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Change From Baseline to Week 8 in Analog Scales- Firmness [baseline to Week 8]
mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- Maintenance [baseline to Week 8]
mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- Reliability [baseline to Week 8]
mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance [baseline to week 8]
mean change - scale of 0 (worst) to 10 (best)
Analog Scales- Firmness [Week 8, Week 14]
mean - scale of 0 (worst) to 10 (best)
Analog Scales- Maintenance [Week 8, Week 14]
mean - scale of 0 (worst) to 10 (best)
Analog Scales- Reliability [Week 8, Week 14]
mean - scale of 0 (worst) to 10 (best)
Analog Scales- General Sexual Performance [Week 8, Week 14]
mean - scale of 0 (worst) to 10 (best)
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 [Week 8 to Week 14]
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Shift in Responder Rate From Week 8 to Week 14 for GEQ2 [Week 8 to Week 14]
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Shift in Responder Rate From Week 8 to Week 14 for GEQ3 [Week 8 to Week 14]
GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 [Baseline to <= Week 14]
Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 [Baseline to <Week 8 and Week 8 to <=Week 14]
Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections [Baseline to <Week 8 and Week 8 to <=Week 14]
Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Men above age of majority
Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion Criteria:

Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
Subjects currently taking any other commercially available drug or non-drug treatment for ED

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Calgary	Alberta	Canada	T2L 1K8
2	Pfizer Investigational Site	Calgary	Alberta	Canada	T2V 4R6
3	Pfizer Investigational Site	Edmonton	Alberta	Canada	T5H 4B9
4	Pfizer Investigational Site	Langley	British Columbia	Canada	V3A 4H9
5	Pfizer Investigational Site	Surrey	British Columbia	Canada	V3V 1N1
6	Pfizer Investigational Site	Vancouver	British Columbia	Canada	V5Z 1K3
7	Pfizer Investigational Site	Vancouver	British Columbia	Canada	V6Z 2T1
8	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8T 5G1
9	Pfizer Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada	A0A 1G0
10	Pfizer Investigational Site	Halifax	Nova Scotia	Canada	B3H 3A7
11	Pfizer Investigational Site	Barrie	Ontario	Canada	L4M 7G1
12	Pfizer Investigational Site	Corunna	Ontario	Canada	N0N 1G0
13	Pfizer Investigational Site	Kingston	Ontario	Canada	K7L 3J7
14	Pfizer Investigational Site	London	Ontario	Canada	N6A 4V2
15	Pfizer Investigational Site	Oakville	Ontario	Canada	L6H 3P1
16	Pfizer Investigational Site	Sarnia	Ontario	Canada	N7T 4X3
17	Pfizer Investigational Site	Toronto	Ontario	Canada	M5T 2S8
18	Pfizer Investigational Site	Toronto	Ontario	Canada	M6A 3B5
19	Pfizer Investigational Site	Chicoutimi	Quebec	Canada	G7H 4A3
20	Pfizer Investigational Site	L'Ancienne-Lorette	Quebec	Canada	G2E 2X1
21	Pfizer Investigational Site	Montreal	Quebec	Canada	H2L 5B1
22	Pfizer Investigational Site	Montreal	Quebec	Canada	H2X 1N8
23	Pfizer Investigational Site	Montreal	Quebec	Canada	H3S 1Z1
24	Pfizer Investigational Site	Montréal	Quebec	Canada	H2X 1N8
25	Pfizer Investigational Site	Pointe-Claire	Quebec	Canada	H9R 4S3
26	Pfizer Investigational Site	Sherbrooke	Quebec	Canada	J1H 1Z1
27	Pfizer Investigational Site	St. Leonard	Quebec	Canada	H1S 3A9

Sponsors and Collaborators

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

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:

NCT00301262

Other Study ID Numbers:

A1481238

First Posted:

Mar 10, 2006

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Additional relevant MeSH terms:

Erectile Dysfunction

Sildenafil Citrate

Study Results

Participant Flow

Recruitment Details	31 centers in Canada
Pre-assignment Detail	183 subjects entered the study, and 176 subjects were treated in the Double Blind (DB) phase. One subject completed DB phase and continued into the open-label (OL) phase but had no events of sexual activity and therefore, did not take study drug and was excluded from the number of treated subjects, the safety analysis set, and PP population.

Arm/Group Title	DB Viagra / OL Viagra	DB Placebo/OL Viagra
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
Period Title: Double Blind Phase (DB)
STARTED	94	82
COMPLETED	84	69
NOT COMPLETED	10	13
Period Title: Double Blind Phase (DB)
STARTED	83	69
COMPLETED	79	67
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Start : DB Viagra	Start : DB Placebo	Total
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).	Total of all reporting groups
Overall Participants	94	82	176
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.6 (12.5)	48.0 (11.9)	49.9 (12.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	94 100%	82 100%	176 100%

Outcome Measures

1. Primary Outcome

Title	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
Description	adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the Full Analysis Set (FAS) population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	88	73
Least Squares Mean (Standard Error) [scores on a scale]	80.27 (2.329)	62.15 (2.524)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments	The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.13
	Confidence Interval	() 95% 11.40 to 24.86
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.405
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

2. Secondary Outcome

Title	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Description	Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	88	80	73	67
Mean (Standard Deviation) [scores on a scale]	79.21 (19.646)	84.12 (17.220)	61.64 (22.752)	87.42 (15.124)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0028
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.09
	Confidence Interval	() 95% 1.800 to 8.370
	Parameter Dispersion	Type: Standard Deviation Value: 14.761
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	26.02
	Confidence Interval	() 95% 20.580 to 31.455
	Parameter Dispersion	Type: Standard Deviation Value: 22.294
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

3. Secondary Outcome

Title	Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
Description	adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	3.97 (0.498)	2.21 (0.536)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0080
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.76
	Confidence Interval	() 95% 0.47 to 3.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.656
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

4. Secondary Outcome

Title	Patient Reported Erectile Function Assessment (PREFA) Total Score
Description	PREFA Total Score: 8 = worst, 32 = best.
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra /OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	28.54 (3.468)	29.58 (2.988)	26.79 (3.753)	29.73 (2.895)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0051
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.94
	Confidence Interval	() 95% 0.290 to 1.585
	Parameter Dispersion	Type: Standard Deviation Value: 2.909
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.79
	Confidence Interval	() 95% 1.812 to 3.770
	Parameter Dispersion	Type: Standard Deviation Value: 4.013
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

5. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Description	adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	2.08 (0.642)	-0.53 (0.698)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0054
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.61
	Confidence Interval	() 95% 0.78 to 4.43
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.922
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

6. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Description	adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	0.59 (0.248)	0.30 (0.271)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4232
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.30
	Confidence Interval	() 95% -0.43 to 1.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.368
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

7. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Description	adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	0.60 (0.207)	-0.08 (0.223)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0156
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.68
	Confidence Interval	() 95% 0.13 to 1.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.277
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

8. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Description	adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	2.20 (0.365)	1.00 (0.390)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0096
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.20
	Confidence Interval	() 95% 0.30 to 2.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.458
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

9. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Description	adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	2.35 (0.254)	1.46 (0.275)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0135
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.90
	Confidence Interval	() 95% 0.19 to 1.61
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.359
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

10. Secondary Outcome

Title	International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Description	Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	24.92 (5.375)	26.43 (5.023)	22.40 (6.403)	27.67 (3.573)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0033
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.49
	Confidence Interval	() 95% 0.0510 to 2.465
	Parameter Dispersion	Type: Standard Deviation Value: 4.392
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.22
	Confidence Interval	() 95% 3.676 to 6.772
	Parameter Dispersion	Type: Standard Deviation Value: 6.346
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

11. Secondary Outcome

Title	International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Description	Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	8.62 (1.812)	8.95 (1.598)	7.81 (2.564)	9.21 (1.213)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2581
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.20
	Confidence Interval	() 95% -0.149 to 0.549
	Parameter Dispersion	Type: Standard Deviation Value: 1.570
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.39
	Confidence Interval	() 95% 0.758 to 2.018
	Parameter Dispersion	Type: Standard Deviation Value: 2.582
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

12. Secondary Outcome

Title	International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Description	Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	7.90 (1.665)	8.10 (1.539)	7.37 (1.712)	8.18 (1.230)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2857
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.18
	Confidence Interval	() 95% -0.149 to 0.499
	Parameter Dispersion	Type: Standard Deviation Value: 1.456
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.76
	Confidence Interval	() 95% 0.345 to 1.177
	Parameter Dispersion	Type: Standard Deviation Value: 1.706
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

13. Secondary Outcome

Title	International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Description	Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	11.82 (2.806)	12.64 (2.367)	10.84 (2.635)	13.12 (1.943)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0102
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.75
	Confidence Interval	() 95% 0.183 to 1.317
	Parameter Dispersion	Type: Standard Deviation Value: 2.548
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.28
	Confidence Interval	() 95% 1.557 to 3.010
	Parameter Dispersion	Type: Standard Deviation Value: 2.979
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

14. Secondary Outcome

Title	International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Description	Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	8.19 (1.827)	8.94 (1.656)	7.25 (2.178)	9.12 (1.332)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.68
	Confidence Interval	() 95% 0.264 to 1.086
	Parameter Dispersion	Type: Standard Deviation Value: 1.847
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.90
	Confidence Interval	() 95% 1.335 to 2.456
	Parameter Dispersion	Type: Standard Deviation Value: 2.297
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

15. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
Description	adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	5.14 (0.870)	2.36 (0.926)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0083
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.78
	Confidence Interval	() 95% 0.73 to 4.83
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.038
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

16. Secondary Outcome

Title	Erectile Distress Scale (EDS) Total Score
Description	Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	24.58 (6.039)	24.55 (6.552)	21.23 (6.246)	26.58 (4.717)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9146
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.06
	Confidence Interval	() 95% -1.218 to 1.093
	Parameter Dispersion	Type: Standard Deviation Value: 5.193
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.54
	Confidence Interval	() 95% 3.961 to 7.114
	Parameter Dispersion	Type: Standard Deviation Value: 6.463
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

17. Secondary Outcome

Title	Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
Description	adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Least Squares Mean (Standard Error) [scores on a scale]	24.04 (3.260)	5.62 (3.558)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.42
	Confidence Interval	() 95% 8.88 to 27.96
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.826
	Estimation Comments	Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

18. Secondary Outcome

Title	Quality of Erection Questionnaire (QEQ) Total Score
Description	QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [scores on a scale]	80.20 (23.954)	86.46 (20.918)	63.64 (28.559)	89.74 (17.473)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0064
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	6.41
	Confidence Interval	() 95% 1.857 to 10.956
	Parameter Dispersion	Type: Standard Deviation Value: 20.444
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	26.80
	Confidence Interval	(2-Sided) 95% 19.636 to 33.971
	Parameter Dispersion	Type: Standard Deviation Value: 29.384
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

19. Secondary Outcome

Title	Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Description	GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	Week 8 DB Viagra	Week 8 DB Placebo	Week 14 DB Viagra/OL Viagra	Week 14 DB Placebo/OL Viagra
Arm/Group Description
Measure Participants	88	73	80	67
GEQ1 Responder	81.8	43.8	90.0	94.0
GEQ1 Non-Responder	18.2	56.2	10.0	6.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.491
	Confidence Interval	() 95% 3.042 to 13.851
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Description	GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	Week 8 DB Viagra	Week 8 DB Placebo	Week 14 DB Viagra/OL Viagra	Week 14 DB Placebo/OL Viagra
Arm/Group Description
Measure Participants	88	73	80	67
GEQ2 Responder	79.3	45.2	86.3	92.5
GEQ2 Non-Responder	20.7	54.8	13.8	7.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.915
	Confidence Interval	() 95% 2.396 to 10.080
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Description	GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	Week 8 DB Viagra	Week 8 DB Placebo	Week 14 DB Viagra/OL Viagra	Week 14 DB Placebo/OL Viagra
Arm/Group Description
Measure Participants	88	73	80	67
GEQ3 Responders	94.3	81.7	95.0	98.5
GEQ3 Non-Responders	5.7	18.3	5.0	1.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0187
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.676
	Confidence Interval	() 95% 1.242 to 10.875
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Percentage of Occasions of Successful Intercourse (Event Log)
Description	Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
Measure Participants	88	73
Mean (Standard Deviation) [percentage of occasions]	73.64 (26.689)	59.73 (33.332)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0037
	Comments
	Method	independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	13.90
	Confidence Interval	() 95% 4.59 to 23.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.716
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

23. Secondary Outcome

Title	Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Description	Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
Measure Participants	88	73
Mean (Standard Deviation) [Percentage of occasions]	74.31 (25.300)	64.60 (31.903)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0321
	Comments
	Method	independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.72
	Confidence Interval	() 95% 0.84 to 18.60
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.496
	Estimation Comments	Mean Difference = Week 8 - Baseline

24. Secondary Outcome

Title	Percentage of Occasions of Successful Intercourse (Event Log)
Description	Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Week 8 to Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra / OL Viagra	DB Placebo/OL Viagra
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
Measure Participants	80	67
Mean (Standard Deviation) [percentage of occasions]	79.65 (25.309)	87.63 (21.936)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0427
	Comments
	Method	independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.97
	Confidence Interval	() 95% -15.68 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.901
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

25. Secondary Outcome

Title	Percentage of Occasions of Ejaculation and/or Orgasm Event Log
Description	Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Week 8 to Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra / OL Viagra	DB Placebo/OL Viagra
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
Measure Participants	80	67
Mean (Standard Deviation) [percentage of occasions]	77.69 (25.099)	85.29 (22.257)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0533
	Comments
	Method	independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.60
	Confidence Interval	() 95% -15.32 to 0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.903
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

26. Secondary Outcome

Title	Change From Baseline to Week 8 in Analog Scales- Firmness
Description	mean change - scale of 0 (worst) to 10 (best).
Time Frame	baseline to Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description
Measure Participants	89	73
Mean (Standard Deviation) [units on a scale]	1.55 (2.023)	0.38 (1.800)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	2-sample independent t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.1670
	Confidence Interval	() 95% 0.566 to 1.768
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3041
	Estimation Comments	A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).

27. Secondary Outcome

Title	Change From Baseline to Week 8 in Analog Scales- Maintenance
Description	mean change - scale of 0 (worst) to 10 (best).
Time Frame	baseline to Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
Measure Participants	89	73
Mean (Standard Deviation) [units on a scale]	1.84 (2.421)	0.40 (2.152)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	2-sample independent t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.4454
	Confidence Interval	() 95% 0.727 to 2.164
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3638
	Estimation Comments	A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).

28. Secondary Outcome

Title	Change From Baseline to Week 8 in Analog Scales- Reliability
Description	mean change - scale of 0 (worst) to 10 (best).
Time Frame	baseline to Week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
Measure Participants	89	73
Mean (Standard Deviation) [units on a scale]	1.61 (2.795)	0.42 (2.081)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0032
	Comments
	Method	2-sample independent t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.1821
	Confidence Interval	() 95% 0.403 to 1.961
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3946
	Estimation Comments	A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).

29. Secondary Outcome

Title	Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
Description	mean change - scale of 0 (worst) to 10 (best)
Time Frame	baseline to week 8

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra	DB Placebo
Arm/Group Description	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
Measure Participants	89	73
Mean (Standard Deviation) [units on a scale]	1.72 (2.355)	0.51 (2.109)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	2-sample independent t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.2123
	Confidence Interval	() 95% 0.511 to 1.913
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3549
	Estimation Comments	A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).

30. Secondary Outcome

Title	Analog Scales- Firmness
Description	mean - scale of 0 (worst) to 10 (best)
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [units on a scale]	7.87 (1.872)	8.25 (1.932)	6.60 (2.171)	8.64 (1.264)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0195
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.39
	Confidence Interval	() 95% 0.064 to 0.711
	Parameter Dispersion	Type: Standard Deviation Value: 1.454
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.09
	Confidence Interval	() 95% 1.551 to 2.628
	Parameter Dispersion	Type: Standard Deviation Value: 2.207
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

31. Secondary Outcome

Title	Analog Scales- Maintenance
Description	mean - scale of 0 (worst) to 10 (best)
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [units on a scale]	7.65 (2.138)	8.01 (2.155)	5.99 (2.519)	8.55 (1.617)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0186
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.40
	Confidence Interval	() 95% 0.069 to 0.731
	Parameter Dispersion	Type: Standard Deviation Value: 1.489
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.67
	Confidence Interval	() 95% 2.044 to 3.299
	Parameter Dispersion	Type: Standard Deviation Value: 2.573
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

32. Secondary Outcome

Title	Analog Scales- Reliability
Description	mean - scale of 0 (worst) to 10 (best)
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [units on a scale]	7.35 (2.360)	7.96 (2.292)	6.04 (2.306)	8.55 (1.550)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0033
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.65
	Confidence Interval	() 95% 0.223 to 1.077
	Parameter Dispersion	Type: Standard Deviation Value: 1.917
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.61
	Confidence Interval	() 95% 2.042 to 3.182
	Parameter Dispersion	Type: Standard Deviation Value: 2.335
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

33. Secondary Outcome

Title	Analog Scales- General Sexual Performance
Description	mean - scale of 0 (worst) to 10 (best)
Time Frame	Week 8, Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Week 8	DB Viagra/OL Viagra Week 14	DB Placebo Week 8	DB Placebo/OL Viagra Week 14
Arm/Group Description
Measure Participants	89	80	73	67
Mean (Standard Deviation) [units on a scale]	7.58 (2.077)	8.01 (1.978)	6.53 (2.128)	8.49 (1.319)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0143
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.45
	Confidence Interval	() 95% 0.093 to 0.807
	Parameter Dispersion	Type: Standard Deviation Value: 1.606
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.99
	Confidence Interval	() 95% 1.454 to 2.516
	Parameter Dispersion	Type: Standard Deviation Value: 2.178
	Estimation Comments	A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).

34. Secondary Outcome

Title	Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
Description	GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Time Frame	Week 8 to Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.

Arm/Group Title	DB Viagra / OL Viagra	DB Placebo/ OL Viagra
Arm/Group Description
Measure Participants	80	67
Responder at Week 8 / Responder at Week 14	61	27
Responder at Week 8 / Non-Responder at Week 14	3	0
Non-Responder at Week 8 / Responder at Week 14	11	36
Non-Responder at Week 8 / Non-Responder at Week 14	5	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra
	Comments	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0325
	Comments
	Method	McNemar
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo
	Comments	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments

35. Secondary Outcome

Title	Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Description	GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Time Frame	Week 8 to Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.

Arm/Group Title	DB Viagra / OL Viagra	DB Placebo / OL Viagra
Arm/Group Description
Measure Participants	79	67
Responder at Week 8 / Responder at Week 14	60	29
Responder at Week 8 / Non-Responder at Week 14	1	0
Non-Responder at Week 8 / Responder at Week 14	8	33
Non-Responder at Week 8 / Non-Responder at Week 14	10	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra
	Comments	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0196
	Comments
	Method	McNemar
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo
	Comments	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments

36. Secondary Outcome

Title	Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Description	GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Time Frame	Week 8 to Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.

Arm/Group Title	DB Viagra / OL Viagra	DB Placebo / OL Viagra
Arm/Group Description
Measure Participants	79	65
Responder at Week 8 / Responder at Week 14	74	54
Responder at Week 8 / Non-Responder at Week 14	0	0
Non-Responder at Week 8 / Responder at Week 14	1	10
Non-Responder at Week 8 / Non-Responder at Week 14	4	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra
	Comments	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3173
	Comments
	Method	McNemar
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo
	Comments	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	McNemar
	Comments

37. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Description	Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline to < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	7.09 (13.041)	12.64 (23.834)	4.50 (12.217)	3.12 (9.855)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0624
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.55
	Confidence Interval	() 95% -11.39 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.958
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4523
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.38
	Confidence Interval	() 95% -2.24 to 5.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.835
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

38. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Description	Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <= Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	3.83 (9.600)	6.31 (15.144)	3.48 (14.300)	1.88 (8.269)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2081
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.48
	Confidence Interval	() 95% -6.35 to 1.40
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.962
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4131
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.61
	Confidence Interval	() 95% -2.26 to 5.48
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.958
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

39. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Description	Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	6.96 (11.858)	8.72 (15.190)	4.62 (10.038)	2.26 (7.813)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4069
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.77
	Confidence Interval	() 95% -5.97 to 2.43
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.126
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1137
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.37
	Confidence Interval	() 95% -0.57 to 5.31
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.489
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

40. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Description	Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	34.94 (29.253)	47.17 (32.167)	29.50 (28.515)	30.12 (31.412)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0123
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.23
	Confidence Interval	() 95% -21.77 to -2.70
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.829
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8993
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.62
	Confidence Interval	() 95% -10.27 to 9.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.883
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

41. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Description	Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	47.19 (35.293)	25.16 (33.764)	57.89 (35.934)	62.63 (35.112)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	22.03
	Confidence Interval	() 95% 11.25 to 32.81
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.458
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4165
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.74
	Confidence Interval	() 95% -16.24 to 6.76
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.818
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

42. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Description	Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	82.13 (23.476)	72.33 (31.798)	87.39 (22.496)	92.75 (15.386)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0257
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.80
	Confidence Interval	() 95% 1.21 to 18.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.351
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0971
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.36
	Confidence Interval	() 95% -11.70 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.209
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

43. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Description	Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	73	38	61	51
Mean (Standard Deviation) [percentage of occasions]	0.00 (0.000)	3.18 (15.052)	0.13 (0.985)	2.17 (14.014)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0726
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.18
	Confidence Interval	() 95% -6.66 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.754
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2581
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.04
	Confidence Interval	() 95% -5.61 to 1.52
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.798
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

44. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Description	Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	73	38	61	51
Mean (Standard Deviation) [percentage of occasions]	6.43 (22.211)	7.47 (22.317)	1.70 (9.143)	2.03 (8.638)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8158
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.04
	Confidence Interval	() 95% -9.86 to 7.78
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.450
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8464
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.33
	Confidence Interval	() 95% -3.68 to 3.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.692
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

45. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Description	Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	73	38	61	51
Mean (Standard Deviation) [percentage of occasions]	14.93 (28.145)	15.27 (30.431)	11.96 (24.555)	12.66 (28.294)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.9529
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.34
	Confidence Interval	() 95% -11.82 to 11.13
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.789
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.8899
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.69
	Confidence Interval	() 95% -10.59 to 9.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.994
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

46. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Description	Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	73	38	61	51
Mean (Standard Deviation) [percentage of occasions]	37.41 (38.658)	47.59 (41.025)	42.97 (38.322)	33.29 (31.633)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.2001
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.18
	Confidence Interval	() 95% -25.83 to 5.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.897
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.1527
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.68
	Confidence Interval	() 95% -3.64 to 23.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.724
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

47. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Description	Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	73	38	61	51
Mean (Standard Deviation) [percentage of occasions]	41.23 (41.013)	26.49 (34.300)	43.24 (39.891)	49.86 (36.921)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0606
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.74
	Confidence Interval	() 95% -0.67 to 30.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.774
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.3678
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.62
	Confidence Interval	() 95% -21.12 to 7.88
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.318
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

48. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Description	Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	73	38	61	51
Mean (Standard Deviation) [percentage of occasions]	78.64 (35.395)	74.08 (40.922)	86.21 (27.647)	83.14 (31.561)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5429
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.56
	Confidence Interval	() 95% -10.25 to 19.37
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.474
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.5849
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.07
	Confidence Interval	() 95% -8.02 to 14.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.595
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

49. Secondary Outcome

Title	Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Description	Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame	Baseline to <Week 8 and Week 8 to <=Week 14

Outcome Measure Data

Analysis Population Description
number of subjects in the FAS population with an observation

Arm/Group Title	DB Viagra Baseline < Week 8	DB Placebo Baseline < Week 8	DB Viagra/OL Viagra Week 8 to <=Week 14	DB Placebo/OL Viagra Week 8 to <=Week 14
Arm/Group Description
Measure Participants	88	74	83	68
Mean (Standard Deviation) [percentage of occasions]	38.06 (33.287)	19.20 (28.977)	44.07 (38.632)	39.15 (37.159)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DB Viagra, DB Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	18.86
	Confidence Interval	() 95% 9.08 to 28.64
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.952
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DB Placebo Week 8, DB Placebo/OL Viagra Week 14
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.4290
	Comments
	Method	Independent-samples t-test
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.93
	Confidence Interval	() 95% -7.35 to 17.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.212
	Estimation Comments	Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.

Adverse Events

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:

NCT00301262

Other Study ID Numbers:

A1481238

First Posted:

Mar 10, 2006

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021