Status:
COMPLETED
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Lead Sponsor:
Sprout Pharmaceuticals, Inc
Conditions:
Sexual Dysfunctions, Psychological
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
Brief 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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
949 Patients enrolled
Trial Details
Trial ID
NCT00996372
Start Date
October 1 2009
End Date
March 1 2011
Last Update
June 12 2014
Active Locations (75)
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1
511.130.01074 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
511.130.01046 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
3
511.130.01042 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
4
511.130.01025 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States