Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

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

Details

• Lead Sponsor: Sprout Pharmaceuticals, Inc

Criteria

Inclusion criteria:

1. Premenopausal women who are 18 years old and older

2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.

3. Stable, monogamous heterosexual relationship for at least one year.

4. Willing to discuss sexual issues.

5. Willing to engage in sexual activity at least once a month

6. Normal pap smear

7. Must use medically acceptable method of contraception

8. Able to comply with daily use of a handheld entry device

Exclusion criteria:

1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.

2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.

3. Partner with inadequately treated organic or psychosexual dysfunction

4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.

5. Sexual function impaired by psychiatric disorder

6. Sexual function impaired by gynecological disorder

7. Major life stress that could impair sexual function

8. Substance abuse