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NCT00384930 · ClinicalTrials.gov registry record · Phase 2
Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,058
- Enrollment target
NCT00384930: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT00384930 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,058 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (695% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00384930, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,058 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.
Primary Outcome
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Interventions
- DRUG placebo
- DRUG tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,058 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00384930 record still lists
NCT00384930 is an interventional study that assigns participants to a tested intervention. Its 1,058 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (695% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00384930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00384930 about?
NCT00384930 is a clinical study titled "Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia". This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.
What is the current status of trial NCT00384930?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,058 participants. The study started on 2006-08. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00384930?
The interventions under investigation include: placebo (DRUG), tadalafil (DRUG).
Who is sponsoring clinical trial NCT00384930?
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 NCT00384930's enrollment target sits among peer trials
1,058 24th of 2000 higher than 1,977 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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