Phase 3 N=949 Randomized Double-blind Treatment

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

Sexual Dysfunctions, Psychological

Bottom Line

View on ClinicalTrials.gov: NCT00996372 ↗

Enrolled (actual)

949

Serious AEs

1.3%

Results posted

Jun 2014

Primary outcome: Primary: Change From Baseline in the Number of Satisfying Sexual Events — 1.0; 0.6 sexual events

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: flibanserin (Drug); placebo (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: Female
Sponsor: Sprout Pharmaceuticals, Inc
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Number of Satisfying Sexual Events	1.0; 0.6	—
PRIMARY Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain	0.7; 0.4	—
SECONDARY Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)	-0.8; -0.6	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00996372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.