Conditions: Sexual Dysfunctions, Psychological
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 880
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:
This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.

Arms:
arm 1: flibanserin 50 mg q.h.s. arm 2: flibanserin 100 mg q.h.s. arm 3: placebo q.h.s.

Interventions: intervention 1: flibanserin
Intervention descriptions: intervention 1: flibanserin placebo versus 50 mg qhs versus 100 mg qhs

Protocol document: