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

Sprout Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Sexual Dysfunctions, Psychological

Treatments: Drug: Flibanserin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057901

511.156

Details and patient eligibility

About

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.

Enrollment: 748 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

748 participants in 2 patient groups, including a placebo group

Flibanserin 100 mg

Experimental group

Description:

Flibanserin 100 mg administered at bedtime

Treatment:

Drug: Flibanserin

Placebo

Placebo Comparator group

Description:

This is the matched placebo which will be administered two tablets daily at bedtime.

Treatment:

Drug: Placebo