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| Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00360243 |
Purpose
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenop ausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Ef ficacy for flibanserin will be assessed vs. a parallel placebo group.
| Condition | Intervention | Phase |
|
Sexual Dysfunctions, Psychological |
Drug: flibanserin Drug: placebo |
Phase III |
| MedlinePlus related topics: | Female Sexual Dysfunction |
| ChemIDplus related topics: | Flibanserin |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA |
| Enrollment: | 1392 |
| Study Start Date: | July 2006 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 72 Study Locations |
| Boehringer Ingelheim Pharmaceuticals |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 511.70 |
| First Received: | August 3, 2006 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00360243 |
| Health Authority: | United States: Food and Drug Administration |
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