Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00996164 · ClinicalTrials.gov registry record · Phase 3
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 3 study, sponsored by Sprout Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,090
- Enrollment target
NCT00996164: Completed Phase 3 study, sponsored by Sprout Pharmaceuticals.
NCT00996164 is a Phase 3 study that has completed, run by Sprout Pharmaceuticals. The registered enrollment target is 1,090 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996164, a Phase 3 study, has completed, sponsored by Sprout Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,090 participants
- Enrollment target
Study Summary
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
Primary Outcome
The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The
Interventions
- DRUG Placebo
- DRUG Flibanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,090 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
What the finished NCT00996164 record still lists
NCT00996164 is an interventional study that assigns participants to a tested intervention. Its 1,090 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 (41% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00996164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996164 about?
NCT00996164 is a clinical study titled "Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder". The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
What is the current status of trial NCT00996164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,090 participants. The study started on 2009-10. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00996164?
The interventions under investigation include: Placebo (DRUG), Flibanserin (DRUG).
Who is sponsoring clinical trial NCT00996164?
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 NCT00996164's enrollment target sits among peer trials
1,090 267th of 2000 higher than 1,734 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07196722 · 1,092 participants · Phase 2
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
- NCT06671483 · 1,088 participants · Phase 3
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
- NCT03754114 · 1,094 participants · NA
Brain Oxygen Optimization in Severe TBI, Phase 3
- NCT06118983 · 1,094 participants · NA
Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia