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NCT00360243 · ClinicalTrials.gov registry record · Phase 3
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
A Phase 3 study, sponsored by Sprout Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,385
- Enrollment target
NCT00360243: Completed Phase 3 study, sponsored by Sprout Pharmaceuticals.
NCT00360243 is a Phase 3 study that has completed, run by Sprout Pharmaceuticals. The registered enrollment target is 1,385 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00360243, a Phase 3 study, has completed, sponsored by Sprout Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,385 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 meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
Primary Outcome
A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any inf
Interventions
- DRUG placebo
- DRUG flibanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,385 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00360243 record still lists
NCT00360243 is an interventional study that assigns participants to a tested intervention. Its 1,385 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00360243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00360243 about?
NCT00360243 is a clinical study titled "6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA". 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 meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
What is the current status of trial NCT00360243?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,385 participants. The study started on 2006-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00360243?
The interventions under investigation include: placebo (DRUG), flibanserin (DRUG).
Who is sponsoring clinical trial NCT00360243?
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 NCT00360243's enrollment target sits among peer trials
1,385 176th of 2000 higher than 1,825 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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