Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00836693
• Collaborator: (none)
• Enrollment: 217
• Locations: 21
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: tadalafil; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tadalafil	Drug: tadalafil; 5 milligrams (mg) administered orally once a day for 12 weeks; Other Names: Cialis LY450190
Placebo Comparator: Placebo	Drug: placebo; tablet administered orally once a day for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 [Baseline, Week 12]

   Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.

2. Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses [Baseline, Week 12]

   Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per participant.

3. Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses [Baseline, 12 weeks]

   Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.

Secondary Outcome Measures

1. Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night [Baseline, Week 12]

   NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.

2. Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night [Baseline, Week 12]

   NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.

3. Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change [Baseline, Week 12]

   NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.

4. Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary [Baseline, 12 weeks]

   The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.

5. The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint [Week 12]

   The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).

6. Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire [Baseline, Week 12]

   SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.

7. Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) [Baseline, Week 12]

   Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.

8. Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) [Baseline, 12 weeks]

   Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.

9. Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) [Baseline, Week 12]

   Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.

10. Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) [Baseline, 12 weeks]

    Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.

11. Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses [Baseline, 12 weeks]

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. "Were you able to achieve at least some erection (some enlargement of the penis)? " Data are presented as the mean percentage of yes responses per participant.

12. Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses [Baseline, 12 weeks]

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per participant.

13. Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses [Baseline, 12 weeks]

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per participant.

14. Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint [Week 12]

    GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.

15. Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint [Week 12]

    GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• You are male and aged at least 18 years.

• Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.

• Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study

• You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication

• Your entry laboratory test results and medical tests meet study requirements

• You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.

• If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.

Exclusion Criteria:

• You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.

• Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).

• You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.

• Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.

• Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bad Wiessee		Germany	D-83707
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Berlin		Germany	13465
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hamburg		Germany	20354
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Koblenz		Germany	D-56068
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Leipzig		Germany	04109
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Athens		Greece	11527
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Patras		Greece	26500
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Thessaloniki		Greece	56429
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Catania		Italy	95100
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Firenze		Italy	50139
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	L Aquila		Italy	67100
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Milano		Italy	20132
13	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rome		Italy	00100
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bialystok		Poland	15-223
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Legionowo		Poland	05-120
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lodz		Poland	91-425
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warsaw		Poland	00-631
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aravaca		Spain	28023
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08025
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madrid		Spain	28040
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Majadahonda		Spain	28222

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY(1-877-285-459) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT -5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00836693
• Other Study ID Numbers: 12229; H6D-MC-LVHX
• First Posted: Feb 4, 2009
• Last Update Posted: Jan 4, 2011
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Erectile Dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction; Tadalafil

Study Results

Participant Flow

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Period Title: Overall Study
STARTED	147	70
COMPLETED	130	64
NOT COMPLETED	17	6

Baseline Characteristics

Arm/Group Title	Tadalafil	Placebo	Total
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.	Total of all reporting groups
Overall Participants	147	70	217
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.2 (10.90)	51.9 (10.35)	52.1 (10.71)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	147 100%	70 100%	217 100%
Race/Ethnicity, Customized (participants) [Number]
White	144 98%	69 98.6%	213 98.2%
Asian	2 1.4%	0 0%	2 0.9%
Unknown	1 0.7%	1 1.4%	2 0.9%
Region of Enrollment (participants) [Number]
Germany	39 26.5%	19 27.1%	58 26.7%
Greece	19 12.9%	9 12.9%	28 12.9%
Italy	27 18.4%	13 18.6%	40 18.4%
Poland	31 21.1%	14 20%	45 20.7%
Spain	31 21.1%	15 21.4%	46 21.2%
Body Mass Index (BMI) (kilograms per square meter (kg/m²)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per square meter (kg/m²)]	27.92 (4.685)	27.74 (3.423)	27.86 (4.313)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Description	Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	67
Baseline	15.5 (6.00)	16.0 (6.27)
Week 12 Change	7.3 (6.01)	3.3 (5.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; 2.2 to 5.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.85
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	67
Baseline	60.1 (38.77)	59.9 (38.83)
Week 12 Change	23.2 (31.92)	11.6 (25.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.7
	Confidence Interval	(2-Sided) 95%; 5.1 to 18.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.35
	Estimation Comments

3. Primary Outcome

Title	Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses
Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	67
Baseline	28.2 (31.86)	32.2 (35.93)
Week 12 Change	39.4 (34.71)	19.3 (36.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.0
	Confidence Interval	(2-Sided) 95%; 8.9 to 27.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.60
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
Description	NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline (n=122, n=63)	2.75 (2.270)	2.44 (2.002)
Week 12 Change (n=96, n=49)	-0.11 (2.592)	-0.09 (2.214)

5. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
Description	NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline (n=104, n=56)	28.487 (14.4791)	26.372 (11.8969)
Week 12 Change (n=65, n=33)	-1.553 (16.0073)	-0.398 (12.4585)

6. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
Description	NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	65	33
Mean (Standard Deviation) [percent of volumetric change]	-5.96 (74.647)	-50.30 (150.321)

7. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
Description	The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline (n=145, n=67)	31.0 (27.21)	28.9 (25.74)
Week 12 Change (n=145, n=66)	27.5 (25.29)	11.9 (22.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.2
	Confidence Interval	(2-Sided) 95%; 9.5 to 22.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.37
	Estimation Comments

8. Secondary Outcome

Title	The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
Description	The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Mean (Standard Deviation) [units on a scale]	72.8 (20.66)	52.7 (22.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.001
	Comments	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.0
	Confidence Interval	(2-Sided) 95%; 13.9 to 26.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.11
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
Description	SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Total (Baseline)	47.3 (21.95)	47.9 (21.58)
Total (Change)	20.4 (23.85)	8.3 (21.14)
Sexual Relationship Domain (Baseline)	43.0 (22.54)	43.9 (21.68)
Sexual Relationship Domain (Change)	23.4 (25.88)	9.7 (22.35)
Confidence Domain (Baseline)	53.1 (25.58)	53.1 (24.85)
Confidence Domain (Change)	16.5 (25.58)	6.5 (24.57)
Self-Esteem Domain (Baseline)	50.5 (28.15)	48.5 (30.06)
Self-Esteem Domain (Change)	19.2 (27.85)	9.3 (30.05)
Overall Relationship Domain (Baseline)	58.2 (31.47)	62.3 (29.01)
Overall Relationship Domain (Change)	11.0 (32.51)	0.9 (30.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.7
	Confidence Interval	(2-Sided) 95%; 5.5 to 18.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.17
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.2
	Confidence Interval	(2-Sided) 95%; 6.6 to 19.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.36
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0034
	Comments	p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.9
	Confidence Interval	(2-Sided) 95%; 3.3 to 16.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.34
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0020
	Comments	p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.0
	Confidence Interval	(2-Sided) 95%; 4.1 to 17.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.52
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0653
	Comments	p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.5
	Confidence Interval	(2-Sided) 95%; -0.5 to 15.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.07
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	6.5 (2.99)	7.2 (2.81)
Week 12 Change	2.0 (2.78)	0.5 (2.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.7 to 1.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	6.7 (1.81)	6.6 (1.87)
Week 12 Change	0.5 (1.93)	-0.1 (1.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0089
	Comments	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.2 to 1.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
Description	Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	8.2 (2.65)	7.6 (2.43)
Week 12 Change	2.1 (2.67)	1.5 (2.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0461
	Comments	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.0 to 1.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.37
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	5.2 (2.15)	5.1 (2.11)
Week 12 Change	2.0 (2.37)	0.8 (2.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.7 to 1.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses
Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. "Were you able to achieve at least some erection (some enlargement of the penis)? " Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	80.8 (28.52)	74.2 (34.26)
Week 12 Change	12.5 (24.03)	9.5 (24.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0047
	Comments	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; 2.0 to 10.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.22
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses
Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	11.7 (21.16)	14.6 (23.30)
Week 12 Change	44.1 (35.75)	18.3 (32.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	24.5
	Confidence Interval	(2-Sided) 95%; 14.6 to 34.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.99
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses
Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Baseline	10.3 (20.36)	12.9 (22.11)
Week 12 Change	43.2 (35.52)	18.5 (30.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	ANCOVA
	Comments	Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.5
	Confidence Interval	(2-Sided) 95%; 13.7 to 33.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.96
	Estimation Comments

17. Secondary Outcome

Title	Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
Description	GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Very Much Better	49 (33.6) 33.3%	7 (10.1) 10%
Much Better	41 (28.1) 27.9%	8 (11.6) 11.4%
Little Better	29 (19.9) 19.7%	19 (27.5) 27.1%
No Change	14 (9.6) 9.5%	24 (34.8) 34.3%
A Little Worse	5 (3.4) 3.4%	5 (7.2) 7.1%
Much Worse	4 (1.4) 2.7%	3 (4.3) 4.3%
Very Much Worse	2 (1.4) 1.4%	1 (1.4) 1.4%
Missing	4 (2.7) 2.7%	2 (2.9) 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	Wilcoxon (Mann-Whitney)
	Comments

18. Secondary Outcome

Title	Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
Description	GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Arm/Group Title	Tadalafil	Placebo
Arm/Group Description	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Measure Participants	146	69
Very Much Better	40 (27.4) 27.2%	5 (7.2) 7.1%
Much Better	49 (33.6) 33.3%	11 (15.9) 15.7%
Little Better	28 (19.2) 19%	17 (24.6) 24.3%
No Change	17 (11.6) 11.6%	27 (39.1) 38.6%
A Little Worse	3 (2.1) 2%	4 (5.8) 5.7%
Much Worse	4 2.7%	3 4.3%
Very Much Worse	1 (0.7) 0.7%	0 (0) 0%
Missing	4 (2.7) 2.7%	2 (2.9) 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil, Placebo
	Comments	Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Tadalafil		Placebo
Arm/Group Description	Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)		Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
All Cause Mortality
	Tadalafil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tadalafil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/147 (1.4%)		1/70 (1.4%)
Injury, poisoning and procedural complications
Ankle fracture	0/147 (0%)	0	1/70 (1.4%)	1
Rib fracture	1/147 (0.7%)	1	0/70 (0%)	0
Tibia fracture	0/147 (0%)	0	1/70 (1.4%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/147 (0.7%)	1	0/70 (0%)	0
Respiratory, thoracic and mediastinal disorders
Haemothorax	1/147 (0.7%)	1	0/70 (0%)	0
Other (Not Including Serious) Adverse Events
	Tadalafil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/147 (18.4%)		7/70 (10%)
Cardiac disorders
Arrhythmia	1/147 (0.7%)	1	0/70 (0%)	0
Gastrointestinal disorders
Abdominal pain upper	2/147 (1.4%)	2	0/70 (0%)	0
Dyspepsia	4/147 (2.7%)	4	0/70 (0%)	0
General disorders
Chest pain	1/147 (0.7%)	3	0/70 (0%)	0
Influenza like illness	1/147 (0.7%)	1	0/70 (0%)	0
Infections and infestations
Infective tenosynovitis	1/147 (0.7%)	1	0/70 (0%)	0
Influenza	0/147 (0%)	0	1/70 (1.4%)	1
Nasopharyngitis	4/147 (2.7%)	4	2/70 (2.9%)	2
Pharyngitis	0/147 (0%)	0	1/70 (1.4%)	1
Tonsillitis	1/147 (0.7%)	1	0/70 (0%)	0
Injury, poisoning and procedural complications
Fall	1/147 (0.7%)	1	1/70 (1.4%)	1
Multiple fractures	1/147 (0.7%)	1	0/70 (0%)	0
Procedural headache	1/147 (0.7%)	1	0/70 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	5/147 (3.4%)	5	1/70 (1.4%)	1
Myalgia	4/147 (2.7%)	4	0/70 (0%)	0
Pain in extremity	1/147 (0.7%)	1	0/70 (0%)	0
Nervous system disorders
Burning sensation	1/147 (0.7%)	1	0/70 (0%)	0
Dizziness	1/147 (0.7%)	1	0/70 (0%)	0
Headache	4/147 (2.7%)	4	0/70 (0%)	0
Psychiatric disorders
Dysthymic disorder	0/147 (0%)	0	1/70 (1.4%)	1
Renal and urinary disorders
Renal colic	2/147 (1.4%)	2	0/70 (0%)	0
Urinary retention	1/147 (0.7%)	1	0/70 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	1/147 (0.7%)	1	0/70 (0%)	0
Surgical and medical procedures
Maxillary antrum operation	0/147 (0%)	0	1/70 (1.4%)	1
Tooth extraction	1/147 (0.7%)	1	0/70 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.