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NCT01057901 · ClinicalTrials.gov registry record · Phase 3
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
A Phase 3 study, sponsored by Sprout Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 748
- Enrollment target
NCT01057901: Clinical Trial Phase 3 study, sponsored by Sprout Pharmaceuticals.
NCT01057901 is a Phase 3 study that was terminated before completion, run by Sprout Pharmaceuticals. The registered enrollment target is 748 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01057901, a Phase 3 study, was terminated before completion, sponsored by Sprout Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 748 participants
- Enrollment target
Study Summary
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
Primary Outcome
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Interventions
- DRUG Placebo
- DRUG Flibanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 748 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
Why NCT01057901 stopped before completion
NCT01057901 is an interventional study that assigns participants to a tested intervention. The registered 748 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01057901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01057901 about?
NCT01057901 is a clinical study titled "Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America". The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
What is the current status of trial NCT01057901?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 748 participants. The study started on 2010-01. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01057901?
The interventions under investigation include: Placebo (DRUG), Flibanserin (DRUG).
Who is sponsoring clinical trial NCT01057901?
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 NCT01057901's enrollment target sits among peer trials
748 472nd of 2000 higher than 1,529 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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