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NCT00996372 · ClinicalTrials.gov registry record · Phase 3
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
A Phase 3 study of Sexual Dysfunctions, Psychological, sponsored by Sprout Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 949
- Enrollment target
- 20
- Study locations
NCT00996372: Completed Phase 3 study of Sexual Dysfunctions, Psychological, sponsored by Sprout Pharmaceuticals.
NCT00996372 is a Phase 3 study of Sexual Dysfunctions, Psychological that has completed, run by Sprout Pharmaceuticals. The registered enrollment target is 949 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996372, a Phase 3 study of Sexual Dysfunctions, Psychological, has completed, sponsored by Sprout Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 949 participants
- Enrollment target
- 20
- Study locations
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
A small handheld electronic device (eDiary) was used by 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 could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.
Conditions Studied
Interventions
- DRUG placebo
- DRUG flibanserin
Study Locations (20)
California
- 511.130.01030 Boehringer Ingelheim Investigational Site - Encinitas
- 511.130.01028 Boehringer Ingelheim Investigational Site - Fair Oaks
- 511.130.01037 Boehringer Ingelheim Investigational Site - Irvine
- 511.130.01022 Boehringer Ingelheim Investigational Site - Sacramento
- 511.130.01035 Boehringer Ingelheim Investigational Site - San Diego
- 511.130.01052 Boehringer Ingelheim Investigational Site - San Diego
- 511.130.01016 Boehringer Ingelheim Investigational Site - Torrance
- 511.130.01021 Boehringer Ingelheim Investigational Site - Vista
- 511.130.01051 Boehringer Ingelheim Investigational Site - Westlake Village
Alabama
- 511.130.01074 Boehringer Ingelheim Investigational Site - Birmingham
- 511.130.01046 Boehringer Ingelheim Investigational Site - Huntsville
- 511.130.01042 Boehringer Ingelheim Investigational Site - Mobile
Connecticut
- 511.130.01053 Boehringer Ingelheim Investigational Site - Farmington
- 511.130.01015 Boehringer Ingelheim Investigational Site - Groton
- 511.130.01041 Boehringer Ingelheim Investigational Site - New Britain
Arizona
- 511.130.01025 Boehringer Ingelheim Investigational Site - Phoenix
- 511.130.01073 Boehringer Ingelheim Investigational Site - Phoenix
Colorado
- 511.130.01071 Boehringer Ingelheim Investigational Site - Denver
Delaware
- 511.130.01064 Boehringer Ingelheim Investigational Site - Newark
District of Columbia
- 511.130.01062 Boehringer Ingelheim Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 949 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT00996372 record still lists
NCT00996372 is an interventional study that assigns participants to a tested intervention. The registered 949 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 (23% higher).
The record links to 1 condition, with Sexual Dysfunctions, Psychological appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00996372 names 20 study sites across 7 states, led by California, Alabama, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00996372 about?
NCT00996372 is a clinical study titled "Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women". 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 NCT00996372?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 949 participants. The study started on 2009-10. Estimated completion is 2011-03.
What conditions does trial NCT00996372 study?
This clinical trial studies the following conditions: Sexual Dysfunctions, Psychological.
What interventions are being tested in trial NCT00996372?
The interventions under investigation include: placebo (DRUG), flibanserin (DRUG).
Who is sponsoring clinical trial NCT00996372?
This trial is sponsored by Sprout Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00996372 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00996372's enrollment target sits among peer trials
949 334th of 2000 higher than 1,667 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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