Trial Outcomes & Findings for Effect of Tadalafil Once a Day in Men With Erectile Dysfunction (NCT NCT00836693)

NCT ID: NCT00836693

Last Updated: 2011-01-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 217 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2011-01-04

Participant Flow

Participant milestones

Measure	Tadalafil 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 Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Overall Study STARTED	147	70
Overall Study COMPLETED	130	64
Overall Study NOT COMPLETED	17	6

Reasons for withdrawal

Measure	Tadalafil 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 Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Overall Study Adverse Event	4	1
Overall Study Sponsor Decision	0	1
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	9	4
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

Baseline characteristics by cohort

Measure	Tadalafil n=147 Participants 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 n=70 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.	Total n=217 Participants Total of all reporting groups
Age Continuous	52.2 years STANDARD_DEVIATION 10.90 • n=5 Participants	51.9 years STANDARD_DEVIATION 10.35 • n=7 Participants	52.1 years STANDARD_DEVIATION 10.71 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	70 Participants n=7 Participants	217 Participants n=5 Participants
Race/Ethnicity, Customized White	144 participants n=5 Participants	69 participants n=7 Participants	213 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	39 participants n=5 Participants	19 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Greece	19 participants n=5 Participants	9 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment Italy	27 participants n=5 Participants	13 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Poland	31 participants n=5 Participants	14 participants n=7 Participants	45 participants n=5 Participants
Region of Enrollment Spain	31 participants n=5 Participants	15 participants n=7 Participants	46 participants n=5 Participants
Body Mass Index (BMI)	27.92 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.685 • n=5 Participants	27.74 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.423 • n=7 Participants	27.86 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.313 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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.

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=67 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 Baseline	15.5 units on a scale Standard Deviation 6.00	16.0 units on a scale Standard Deviation 6.27
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 Week 12 Change	7.3 units on a scale Standard Deviation 6.01	3.3 units on a scale Standard Deviation 5.98

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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.

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=67 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses Baseline	60.1 percentage of yes responses Standard Deviation 38.77	59.9 percentage of yes responses Standard Deviation 38.83
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses Week 12 Change	23.2 percentage of yes responses Standard Deviation 31.92	11.6 percentage of yes responses Standard Deviation 25.48

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: 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.

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=67 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses Baseline	28.2 percentage of yes responses Standard Deviation 31.86	32.2 percentage of yes responses Standard Deviation 35.93
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses Week 12 Change	39.4 percentage of yes responses Standard Deviation 34.71	19.3 percentage of yes responses Standard Deviation 36.18

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night Baseline (n=122, n=63)	2.75 Number of events per night Standard Deviation 2.270	2.44 Number of events per night Standard Deviation 2.002
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night Week 12 Change (n=96, n=49)	-0.11 Number of events per night Standard Deviation 2.592	-0.09 Number of events per night Standard Deviation 2.214

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night Baseline (n=104, n=56)	28.487 minutes Standard Deviation 14.4791	26.372 minutes Standard Deviation 11.8969
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night Week 12 Change (n=65, n=33)	-1.553 minutes Standard Deviation 16.0073	-0.398 minutes Standard Deviation 12.4585

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Measure	Tadalafil n=65 Participants 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 n=33 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change	-5.96 percent of volumetric change Standard Deviation 74.647	-50.30 percent of volumetric change Standard Deviation 150.321

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary Baseline (n=145, n=67)	31.0 percent Standard Deviation 27.21	28.9 percent Standard Deviation 25.74
Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary Week 12 Change (n=145, n=66)	27.5 percent Standard Deviation 25.29	11.9 percent Standard Deviation 22.00

SECONDARY outcome

Timeframe: Week 12

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

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).

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint	72.8 units on a scale Standard Deviation 20.66	52.7 units on a scale Standard Deviation 22.62

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Confidence Domain (Change)	16.5 units on a scale Standard Deviation 25.58	6.5 units on a scale Standard Deviation 24.57
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Self-Esteem Domain (Baseline)	50.5 units on a scale Standard Deviation 28.15	48.5 units on a scale Standard Deviation 30.06
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Self-Esteem Domain (Change)	19.2 units on a scale Standard Deviation 27.85	9.3 units on a scale Standard Deviation 30.05
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Overall Relationship Domain (Baseline)	58.2 units on a scale Standard Deviation 31.47	62.3 units on a scale Standard Deviation 29.01
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Overall Relationship Domain (Change)	11.0 units on a scale Standard Deviation 32.51	0.9 units on a scale Standard Deviation 30.17
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Total (Baseline)	47.3 units on a scale Standard Deviation 21.95	47.9 units on a scale Standard Deviation 21.58
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Total (Change)	20.4 units on a scale Standard Deviation 23.85	8.3 units on a scale Standard Deviation 21.14
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Sexual Relationship Domain (Baseline)	43.0 units on a scale Standard Deviation 22.54	43.9 units on a scale Standard Deviation 21.68
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Sexual Relationship Domain (Change)	23.4 units on a scale Standard Deviation 25.88	9.7 units on a scale Standard Deviation 22.35
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire Confidence Domain (Baseline)	53.1 units on a scale Standard Deviation 25.58	53.1 units on a scale Standard Deviation 24.85

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) Baseline	6.5 units on a scale Standard Deviation 2.99	7.2 units on a scale Standard Deviation 2.81
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) Week 12 Change	2.0 units on a scale Standard Deviation 2.78	0.5 units on a scale Standard Deviation 2.02

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) Baseline	6.7 units on a scale Standard Deviation 1.81	6.6 units on a scale Standard Deviation 1.87
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) Week 12 Change	0.5 units on a scale Standard Deviation 1.93	-0.1 units on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) Baseline	8.2 units on a scale Standard Deviation 2.65	7.6 units on a scale Standard Deviation 2.43
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) Week 12 Change	2.1 units on a scale Standard Deviation 2.67	1.5 units on a scale Standard Deviation 2.56

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) Baseline	5.2 units on a scale Standard Deviation 2.15	5.1 units on a scale Standard Deviation 2.11
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) Week 12 Change	2.0 units on a scale Standard Deviation 2.37	0.8 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses Baseline	80.8 percentage of yes responses Standard Deviation 28.52	74.2 percentage of yes responses Standard Deviation 34.26
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses Week 12 Change	12.5 percentage of yes responses Standard Deviation 24.03	9.5 percentage of yes responses Standard Deviation 24.67

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses Baseline	11.7 percentage of yes responses Standard Deviation 21.16	14.6 percentage of yes responses Standard Deviation 23.30
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses Week 12 Change	44.1 percentage of yes responses Standard Deviation 35.75	18.3 percentage of yes responses Standard Deviation 32.14

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses Baseline	10.3 percentage of yes responses Standard Deviation 20.36	12.9 percentage of yes responses Standard Deviation 22.11
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses Week 12 Change	43.2 percentage of yes responses Standard Deviation 35.52	18.5 percentage of yes responses Standard Deviation 30.98

SECONDARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint Very Much Better	49 participants 33.6	7 participants 10.1
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint Much Better	41 participants 28.1	8 participants 11.6
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint Little Better	29 participants 19.9	19 participants 27.5
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint No Change	14 participants 9.6	24 participants 34.8
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint A Little Worse	5 participants 3.4	5 participants 7.2
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint Much Worse	4 participants 1.4	3 participants 4.3
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint Very Much Worse	2 participants 1.4	1 participants 1.4
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint Missing	4 participants 2.7	2 participants 2.9

SECONDARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Measure	Tadalafil n=146 Participants 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 n=69 Participants Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint Much Better	49 participants 33.6	11 participants 15.9
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint Very Much Better	40 participants 27.4	5 participants 7.2
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint Little Better	28 participants 19.2	17 participants 24.6
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint No Change	17 participants 11.6	27 participants 39.1
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint A Little Worse	3 participants 2.1	4 participants 5.8
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint Much Worse	4 participants	3 participants
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint Very Much Worse	1 participants 0.7	0 participants 0
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint Missing	4 participants 2.7	2 participants 2.9

Adverse Events

Tadalafil

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tadalafil n=147 participants at risk 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 n=70 participants at risk Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/147	1.4% 1/70 • Number of events 1
Injury, poisoning and procedural complications Rib fracture	0.68% 1/147 • Number of events 1	0.00% 0/70
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/147	1.4% 1/70 • Number of events 1
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.68% 1/147 • Number of events 1	0.00% 0/70
Respiratory, thoracic and mediastinal disorders Haemothorax	0.68% 1/147 • Number of events 1	0.00% 0/70

Other adverse events

Measure	Tadalafil n=147 participants at risk 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 n=70 participants at risk Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
Cardiac disorders Arrhythmia	0.68% 1/147 • Number of events 1	0.00% 0/70
Gastrointestinal disorders Abdominal pain upper	1.4% 2/147 • Number of events 2	0.00% 0/70
Gastrointestinal disorders Dyspepsia	2.7% 4/147 • Number of events 4	0.00% 0/70
General disorders Chest pain	0.68% 1/147 • Number of events 3	0.00% 0/70
General disorders Influenza like illness	0.68% 1/147 • Number of events 1	0.00% 0/70
Infections and infestations Infective tenosynovitis	0.68% 1/147 • Number of events 1	0.00% 0/70
Infections and infestations Influenza	0.00% 0/147	1.4% 1/70 • Number of events 1
Infections and infestations Nasopharyngitis	2.7% 4/147 • Number of events 4	2.9% 2/70 • Number of events 2
Infections and infestations Pharyngitis	0.00% 0/147	1.4% 1/70 • Number of events 1
Infections and infestations Tonsillitis	0.68% 1/147 • Number of events 1	0.00% 0/70
Injury, poisoning and procedural complications Fall	0.68% 1/147 • Number of events 1	1.4% 1/70 • Number of events 1
Injury, poisoning and procedural complications Multiple fractures	0.68% 1/147 • Number of events 1	0.00% 0/70
Injury, poisoning and procedural complications Procedural headache	0.68% 1/147 • Number of events 1	0.00% 0/70
Musculoskeletal and connective tissue disorders Back pain	3.4% 5/147 • Number of events 5	1.4% 1/70 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	2.7% 4/147 • Number of events 4	0.00% 0/70
Musculoskeletal and connective tissue disorders Pain in extremity	0.68% 1/147 • Number of events 1	0.00% 0/70
Nervous system disorders Burning sensation	0.68% 1/147 • Number of events 1	0.00% 0/70
Nervous system disorders Dizziness	0.68% 1/147 • Number of events 1	0.00% 0/70
Nervous system disorders Headache	2.7% 4/147 • Number of events 4	0.00% 0/70
Psychiatric disorders Dysthymic disorder	0.00% 0/147	1.4% 1/70 • Number of events 1
Renal and urinary disorders Renal colic	1.4% 2/147 • Number of events 2	0.00% 0/70
Renal and urinary disorders Urinary retention	0.68% 1/147 • Number of events 1	0.00% 0/70
Skin and subcutaneous tissue disorders Erythema	0.68% 1/147 • Number of events 1	0.00% 0/70
Surgical and medical procedures Maxillary antrum operation	0.00% 0/147	1.4% 1/70 • Number of events 1
Surgical and medical procedures Tooth extraction	0.68% 1/147 • Number of events 1	0.00% 0/70

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60