Phase 3
N=1,090
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Sexual Dysfunctions, Psychological
Bottom Line
View on ClinicalTrials.gov: NCT00996164 ↗Enrolled (actual)
1,090
Serious AEs
0.5%
Results posted
May 2014
Primary outcome: Primary: The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. — 1.0; 0.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Flibanserin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sprout Pharmaceuticals, Inc
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. |
1.0; 0.7 | — |
| PRIMARY Change From Baseline in the SSE Count From Baseline to 24 Weeks |
2.5; 1.5 | — |
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.
Eligibility Criteria
Inclusion criteria
- Premenopausal women who are 18 years old and older
- 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.
- 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
- Must use medically acceptable method of contraception
- Able to comply with daily use of a handheld entry device
Exclusion criteria
- Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
- 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.
- Partner with inadequately treated organic or psychosexual dysfunction
- History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
- Sexual function impaired by psychiatric disorder
- Sexual function impaired by gynecological disorder
- Major life stress that could impair sexual function
- Substance abuse
Data sourced from ClinicalTrials.gov (NCT00996164). 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.