Status:
COMPLETED
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Lead Sponsor:
Sprout Pharmaceuticals, Inc
Conditions:
Sexual Dysfunctions, Psychological
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
Brief 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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
1090 Patients enrolled
Trial Details
Trial ID
NCT00996164
Start Date
October 1 2009
End Date
February 1 2011
Last Update
May 19 2014
Active Locations (75)
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1
511.147.01074 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
511.147.01046 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
3
511.147.01042 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
4
511.147.01025 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States