Phase 3
Completed N=949
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Sexual Dysfunctions, Psychological
Source: ClinicalTrials.gov NCT00996372 ↗
Enrolled (actual)
949
Serious AEs
1.3%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in the Number of Satisfying Sexual Events — 1.0; 0.6 sexual events
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.
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 | — |
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
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. Informational only — not medical advice.