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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00360529 |
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 |
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Sexual Dysfunctions, Psychological |
Drug: flibanserin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
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) |
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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Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 511.71, VIOLET |
Study First Received: | August 3, 2006 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00360529 |
Health Authority: | Canada: Health Canada (TPD); United States: Food and Drug Administration |
Sexual Dysfunctions, Psychological Mental Disorders Hypokinesia |
Sexual and Gender Disorders |