Conditions: Sexual Dysfunctions, Psychological
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1584
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: flibanserin 25 mg b.i.d arm 2: flibanserin 50mg qhs/b.i.d arm 3: flibanserin 50mg b.i.d./100mg qhs arm 4: placebo comparator

Interventions: intervention 1: flibanserin intervention 2: flibanserin 50mg intervention 3: flibanserin 100mg intervention 4: placebo
Intervention descriptions: intervention 1: flibanserin 25 mg b.i.d intervention 2: flibanserin 50mg qhs/b.i.d. intervention 3: flibanserin 50 mg b.i.d/100mg qhs intervention 4: placebo comparator

Protocol document: