Conditions: Sexual Dysfunctions, Psychological
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1385
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 meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Detailed description:

Arms:
arm 1: 25 mg twice daily for 24 weeks arm 2: 50 mg taken once daily at bedtime for 24 weeks arm 3: 50 mg twice daily for 24 weeks arm 4: twice daily for 24 weeks

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

Protocol document: