Overview

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