Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sprout Pharmaceuticals, Inc

Criteria

Inclusion criteria:

• Naturally postmenopausal women of any age with at least one ovary

• Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration

• Stable, monogamous heterosexual relationship for at least one year

• Willing to discuss sexual issues

• Willing to engage in sexual activity at least once a month

• Normal Pap smear

• Normal mammogram

• Normal uterine lining

• Able to comply with daily use of handheld data entry device

Exclusion criteria:

• Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition

• Partner with inadequately treated organic or psychosexual dysfunction

• Sexual function impaired by psychiatric disorder

• Sexual function impaired by gynecological disorder

• Major Depression

• Suicidal behavior or ideation

• Major life stress that could impair sexual function

• Substance abuse