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NCT01139762 · ClinicalTrials.gov registry record · Phase 3
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 696
- Enrollment target
NCT01139762: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01139762 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 696 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01139762, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 696 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
Primary Outcome
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,
Interventions
- DRUG Placebo
- DRUG Finasteride
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 696 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT01139762 record still lists
NCT01139762 is an interventional study that assigns participants to a tested intervention. The registered 696 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01139762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01139762 about?
NCT01139762 is a clinical study titled "A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms". The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
What is the current status of trial NCT01139762?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 696 participants. The study started on 2010-09. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01139762?
The interventions under investigation include: Placebo (DRUG), Finasteride (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT01139762?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01139762's enrollment target sits among peer trials
696 518th of 2000 higher than 1,483 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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