Trial · NCT00836693

Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

NCT00836693, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-01-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Tadalafil Once a Day in Men With Erectile Dysfunction. Trials, record NCT00836693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00836693

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
NCT number: NCT00836693
Status: Completed
Phases: Phase 3
Enrollment: 217 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Erectile Dysfunction
Interventions: tadalafil, placebo
First posted: 2009-02-04
Last updated: 2011-01-04
Results first posted: 2011-01-04

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12	Baseline, Week 12	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.	units on a scale	MEAN
PRIMARY	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	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.	percentage of yes responses	MEAN
PRIMARY	Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses	Baseline, 12 weeks	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.	percentage of yes responses	MEAN
SECONDARY	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night	Baseline, Week 12	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	Number of events per night	MEAN
SECONDARY	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night	Baseline, Week 12	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	minutes	MEAN
SECONDARY	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change	Baseline, Week 12	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	percent of volumetric change	MEAN
SECONDARY	Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary	Baseline, 12 weeks	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	percent	MEAN
SECONDARY	The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint	Week 12	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	units on a scale	MEAN
SECONDARY	Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire	Baseline, Week 12	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	units on a scale	MEAN
SECONDARY	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)	Baseline, Week 12	The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.	units on a scale	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group108

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12	Tadalafil	Baseline	15.5	Standard Deviation 6.00	units on a scale
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12	Placebo	Baseline	16.0	Standard Deviation 6.27	units on a scale
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12	Tadalafil	Week 12 Change	7.3	Standard Deviation 6.01	units on a scale
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12	Placebo	Week 12 Change	3.3	Standard Deviation 5.98	units on a scale
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses	Tadalafil	Baseline	60.1	Standard Deviation 38.77	percentage of yes responses
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses	Placebo	Baseline	59.9	Standard Deviation 38.83	percentage of yes responses
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses	Tadalafil	Week 12 Change	23.2	Standard Deviation 31.92	percentage of yes responses
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses	Placebo	Week 12 Change	11.6	Standard Deviation 25.48	percentage of yes responses
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses	Tadalafil	Baseline	28.2	Standard Deviation 31.86	percentage of yes responses
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses	Placebo	Baseline	32.2	Standard Deviation 35.93	percentage of yes responses

1 to 10 of 108Source ClinicalTrials.gov

See all 108 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tadalafil	147
Overall Study	STARTED	Placebo	70
Overall Study	COMPLETED	Tadalafil	130
Overall Study	COMPLETED	Placebo	64
Overall Study	NOT COMPLETED	Tadalafil	17
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arrhythmia	Cardiac disorders	Tadalafil	1	147	1
other	Arrhythmia	Cardiac disorders	Placebo	0	70	0
other	Abdominal pain upper	Gastrointestinal disorders	Tadalafil	2	147	2
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	0	70	0
other	Dyspepsia	Gastrointestinal disorders	Tadalafil	4	147	4
other	Dyspepsia	Gastrointestinal disorders	Placebo	0	70	0
other	Chest pain	General disorders	Tadalafil	1	147	3
other	Chest pain	General disorders	Placebo	0	70	0
other	Influenza like illness	General disorders	Tadalafil	1	147	1
other	Influenza like illness	General disorders	Placebo	0	70	0

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tadalafil
Total, all-cause mortality	Placebo
Total, other adverse events	Tadalafil	27	147
Total, other adverse events	Placebo	7	70
Total, serious adverse events	Tadalafil	2	147
Total, serious adverse events	Placebo	1	70

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21707928	DERIVED	PubMed
22790642	DERIVED	PubMed
24119319	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Tadalafil vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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