Trials / Completed
CompletedNCT00360243
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,385 (actual)
- Sponsor
- Sprout Pharmaceuticals, Inc · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | flibanserin | Experimental: flibanserin 25 mg b.i.d |
| DRUG | flibanserin | Experimental: flibanserin 50mg qhs |
| DRUG | flibanserin | Experimental: flibanserin 50mg b.i.d. |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2006-08-04
- Last updated
- 2016-06-27
- Results posted
- 2016-06-27
Locations
81 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00360243. Inclusion in this directory is not an endorsement.