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NCT00360555 · ClinicalTrials.gov registry record · Phase 3
Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 3 study of Sexual Dysfunctions, Psychological, sponsored by Sprout Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,584
- Enrollment target
- 20
- Study locations
NCT00360555: Completed Phase 3 study of Sexual Dysfunctions, Psychological, sponsored by Sprout Pharmaceuticals.
NCT00360555 is a Phase 3 study of Sexual Dysfunctions, Psychological that has completed, run by Sprout Pharmaceuticals. The registered enrollment target is 1,584 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (105% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00360555, a Phase 3 study of Sexual Dysfunctions, Psychological, has completed, sponsored by Sprout Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,584 participants
- Enrollment target
- 20
- Study locations
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
For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms. For satisfying sexual events: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)
Conditions Studied
Interventions
- DRUG placebo
- DRUG flibanserin
- DRUG flibanserin 50mg
- DRUG flibanserin 100mg
Study Locations (20)
California
- 511.75.01017 Boehringer Ingelheim Investigational Site - Berkeley
- 511.75.01014 Boehringer Ingelheim Investigational Site - Encinitas
- 511.75.01042 Boehringer Ingelheim Investigational Site - Fair Oaks
- 511.75.01022 Boehringer Ingelheim Investigational Site - Irvine
- 511.75.01005 Boehringer Ingelheim Investigational Site - La Jolla
- 511.75.01053 Boehringer Ingelheim Investigational Site - Sacremento
- 511.75.01045 Boehringer Ingelheim Investigational Site - San Diego
Florida
- 511.75.01066 Boehringer Ingelheim Investigational Site - Coral Gables
- 511.75.01040 Boehringer Ingelheim Investigational Site - Fort Meyers
- 511.75.01001 Boehringer Ingelheim Investigational Site - Gainesville
- 511.75.01062 Boehringer Ingelheim Investigational Site - Hollywood
- 511.75.01032 Boehringer Ingelheim Investigational Site - Ocala
- 511.75.01047 Boehringer Ingelheim Investigational Site - Orlando
Alabama
- 511.75.01015 Boehringer Ingelheim Investigational Site - Birmingham
- 511.75.01028 Boehringer Ingelheim Investigational Site - Mobile
Colorado
- 511.75.01065 Boehringer Ingelheim Investigational Site - Aurora
- 511.75.01003 Boehringer Ingelheim Investigational Site - Englewood
Arizona
- 511.75.01051 Boehringer Ingelheim Investigational Site - Phoenix
Arkansas
- 511.75.01063 Boehringer Ingelheim Investigational Site - Little Rock
District of Columbia
- 511.75.01030 Boehringer Ingelheim Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,584 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00360555 record still lists
NCT00360555 is an interventional study that assigns participants to a tested intervention. Its 1,584 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 (105% higher).
The record links to 1 condition, with Sexual Dysfunctions, Psychological appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT00360555 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00360555 about?
NCT00360555 is a clinical study titled "Uptitration Trial of Flibanserin Versus Placebo 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 NCT00360555?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,584 participants. The study started on 2006-07. Estimated completion is 2008-03.
What conditions does trial NCT00360555 study?
This clinical trial studies the following conditions: Sexual Dysfunctions, Psychological.
What interventions are being tested in trial NCT00360555?
The interventions under investigation include: placebo (DRUG), flibanserin (DRUG), flibanserin 50mg (DRUG), flibanserin 100mg (DRUG).
Who is sponsoring clinical trial NCT00360555?
This trial is sponsored by Sprout Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00360555 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT00360555's enrollment target sits among peer trials
1,584 149th of 2000 higher than 1,852 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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