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NCT01152190 · ClinicalTrials.gov registry record · Phase 3
A Study in Benign Prostatic Hyperplasia
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 97
- Enrollment target
NCT01152190: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01152190 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 97 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01152190, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 97 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.
Primary Outcome
Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unst
Interventions
- DRUG Placebo
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01152190 record still lists
NCT01152190 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01152190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01152190 about?
NCT01152190 is a clinical study titled "A Study in Benign Prostatic Hyperplasia". The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.
What is the current status of trial NCT01152190?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2010-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01152190?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT01152190?
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 NCT01152190's enrollment target sits among peer trials
97 1718th of 2000 higher than 283 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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