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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00360529 |
Purpose
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexual Dysfunctions, Psychological |
Drug: flibanserin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Every Evening and Flibanserin 100 Milligrams Every Evening in Women With Hypoactive Sexual Desire Disorder in North America |
| Enrollment: | 886 |
| 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 and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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Contacts and Locations
Show 54 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00360529 History of Changes |
| Other Study ID Numbers: | 511.71, VIOLET |
| Study First Received: | August 3, 2006 |
| Last Updated: | April 24, 2009 |
| Health Authority: | Canada: Health Canada (TPD) United States: Food and Drug Administration |
|
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |