Trial · NCT01139762

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

NCT01139762, Phase 3, Completed, Eli Lilly and Company; results first posted 2013-02-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms. Trials, record NCT01139762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01139762

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Trial

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

Title: A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
NCT number: NCT01139762
Status: Completed
Phases: Phase 3
Enrollment: 696 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Benign Prostatic Hyperplasia, Enlarged Prostate
Interventions: Tadalafil, Placebo, Finasteride
First posted: 2010-06-09
Last updated: 2013-02-27
Results first posted: 2013-02-27

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks	Baseline, 12 weeks	The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Secondary	Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks	Baseline, 4 weeks, 26 weeks	The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Secondary	Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Secondary	Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	IPSS Quality of Life Index assesses participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Secondary	Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Secondary	Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Secondary	Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Secondary	Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Secondary	Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Secondary	Patient Global Impression of Improvement (PGI-I) at 26 Weeks	26 weeks	Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks	Baseline, 12 weeks	All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks	Baseline, 4 weeks, 26 weeks	All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks	Baseline, 4 weeks, 12 weeks, 26 weeks	All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Improvement (PGI-I) at 26 Weeks	26 weeks	All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.	participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group98

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

Outcome	Group	Category	Value	Spread	Units
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks	Tadalafil		-5.18	Standard Error 0.32	units on a scale
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks	Placebo		-3.76	Standard Error 0.32	units on a scale
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks	Tadalafil	4 weeks	-3.95	Standard Error 0.29	units on a scale
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks	Placebo	4 weeks	-2.29	Standard Error 0.28	units on a scale
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks	Tadalafil	26 weeks	-5.51	Standard Error 0.33	units on a scale
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks	Placebo	26 weeks	-4.47	Standard Error 0.33	units on a scale
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks	Tadalafil	IPSS storage (irritative) subscore - 4 weeks	-1.27	Standard Error 0.14	units on a scale
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks	Placebo	IPSS storage (irritative) subscore - 4 weeks	-0.76	Standard Error 0.14	units on a scale
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks	Tadalafil	IPSS storage (irritative) subscore - 12 weeks	-1.74	Standard Error 0.14	units on a scale
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks	Placebo	IPSS storage (irritative) subscore - 12 weeks	-1.34	Standard Error 0.14	units on a scale

1 to 10 of 98Source ClinicalTrials.gov

See all 98 results by group

Participant flow21

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

Period	Milestone	Group	Participants
Washout and Placebo Lead-In Period	STARTED	Screening-Washout and Placebo Lead-In	1,070
Washout and Placebo Lead-In Period	STARTED	Tadalafil	0
Washout and Placebo Lead-In Period	STARTED	Placebo	0
Washout and Placebo Lead-In Period	COMPLETED	Screening-Washout and Placebo Lead-In	696
Washout and Placebo Lead-In Period	COMPLETED	Tadalafil	0
Washout and Placebo Lead-In Period	COMPLETED	Placebo	0
Washout and Placebo Lead-In Period	NOT COMPLETED	Screening-Washout and Placebo Lead-In	374
Washout and Placebo Lead-In Period	NOT COMPLETED	Tadalafil	0
Washout and Placebo Lead-In Period	NOT COMPLETED	Placebo	0
Double-Blind Randomized Active Treatment	STARTED	Screening-Washout and Placebo Lead-In	0

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events714

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	Anaemia	Blood and lymphatic system disorders	Screening-Washout and Placebo Lead-In	1	1,070	1
other	Anaemia	Blood and lymphatic system disorders	Tadalafil	0	345	0
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	350	1
other	Leukocytosis	Blood and lymphatic system disorders	Screening-Washout and Placebo Lead-In	1	1,070	1
other	Leukocytosis	Blood and lymphatic system disorders	Tadalafil	0	345	0
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	0	350	0
other	Macrocytosis	Blood and lymphatic system disorders	Screening-Washout and Placebo Lead-In	1	1,070	1
other	Macrocytosis	Blood and lymphatic system disorders	Tadalafil	1	345	1
other	Macrocytosis	Blood and lymphatic system disorders	Placebo	0	350	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Screening-Washout and Placebo Lead-In	0	1,070	0

1 to 10 of 714Source ClinicalTrials.gov

See all 714 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Screening-Washout and Placebo Lead-In
Total, all-cause mortality	Tadalafil
Total, all-cause mortality	Placebo
Total, other adverse events	Screening-Washout and Placebo Lead-In	153	1,070
Total, other adverse events	Tadalafil	105	345
Total, other adverse events	Placebo	94	350
Total, serious adverse events	Screening-Washout and Placebo Lead-In	1	1,070
Total, serious adverse events	Tadalafil	9	345
Total, serious adverse events	Placebo	5	350

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25353053	DERIVED

Source 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 comparisons0

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

None in this release.

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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