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

Completed · Phase 3 · Has a placebo group

Conditions studied: Sexual Dysfunctions, Psychological

In brief

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.

Key facts

Study ID

NCT00996372

Run by

Sprout Pharmaceuticals, Inc

People needed

949

Starts

2009-10-01

Expected to finish

2011-03-01

Last updated by the study team

2014-06-12

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 511.130.01046 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 511.130.01042 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 511.130.01025 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 511.130.01073 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 511.130.01030 Boehringer Ingelheim Investigational Site — Encinitas, California, United States
• 511.130.01028 Boehringer Ingelheim Investigational Site — Fair Oaks, California, United States
• 511.130.01037 Boehringer Ingelheim Investigational Site — Irvine, California, United States
• 511.130.01022 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 511.130.01035 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.130.01052 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.130.01016 Boehringer Ingelheim Investigational Site — Torrance, California, United States
• 511.130.01021 Boehringer Ingelheim Investigational Site — Vista, California, United States
• 511.130.01051 Boehringer Ingelheim Investigational Site — Westlake Village, California, United States
• 511.130.01071 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 511.130.01053 Boehringer Ingelheim Investigational Site — Farmington, Connecticut, United States
• 511.130.01015 Boehringer Ingelheim Investigational Site — Groton, Connecticut, United States
• 511.130.01041 Boehringer Ingelheim Investigational Site — New Britain, Connecticut, United States
• 511.130.01064 Boehringer Ingelheim Investigational Site — Newark, Delaware, United States
• 511.130.01062 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 511.130.01003 Boehringer Ingelheim Investigational Site — Boynton Beach, Florida, United States
• 511.130.01056 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 511.130.01065 Boehringer Ingelheim Investigational Site — Daytona Beach, Florida, United States
• 511.130.01020 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 511.130.01024 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 511.130.01074 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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