Trials / Completed
CompletedNCT00996164
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,090 (actual)
- Sponsor
- Sprout Pharmaceuticals, Inc · Industry
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Flibanserin | patients will be randomized to flibanserin or placebo in a double-blind manner |
| DRUG | Placebo | patients will be randomized to flibanserin or placebo in a double-blind manner |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2010-12-01
- Completion
- 2011-02-01
- First posted
- 2009-10-16
- Last updated
- 2014-05-19
- Results posted
- 2014-05-19
Locations
75 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00996164. Inclusion in this directory is not an endorsement.