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NCT00360529 · ClinicalTrials.gov registry record · Phase 3
24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 3 study, sponsored by Sprout Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 880
- Enrollment target
NCT00360529: Completed Phase 3 study, sponsored by Sprout Pharmaceuticals.
NCT00360529 is a Phase 3 study that has completed, run by Sprout Pharmaceuticals. The registered enrollment target is 880 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00360529, a Phase 3 study, has completed, sponsored by Sprout Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 880 participants
- Enrollment target
Study Summary
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
Primary Outcome
Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
Interventions
- DRUG flibanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 880 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00360529 record still lists
NCT00360529 is an interventional study that assigns participants to a tested intervention. The registered 880 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 1 intervention - of which flibanserin is the first listed.
NCT00360529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00360529 about?
NCT00360529 is a clinical study titled "24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder". This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
What is the current status of trial NCT00360529?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 880 participants. The study started on 2006-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00360529?
The interventions under investigation include: flibanserin (DRUG).
Who is sponsoring clinical trial NCT00360529?
This trial is sponsored by Sprout Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00360529's enrollment target sits among peer trials
880 367th of 2000 higher than 1,631 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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