|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00360555 |
Purpose
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 meets standard diagnostic criteria.
Efficacy for flibanserin will be assessed vs. a parallel placebo group.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexual Dysfunctions, Psychological |
Drug: flibanserin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America |
| Enrollment: | 1584 |
| Study Start Date: | July 2006 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 77 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00360555 History of Changes |
| Other Study ID Numbers: | 511.75 |
| Study First Received: | August 3, 2006 |
| Last Updated: | December 22, 2009 |
| Health Authority: | Canada: Health Canada (TPD); United States: Food and Drug Administration |
|
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |