Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Sexual Dysfunctions, Psychological

In brief

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.

Key facts

Study ID

NCT00996164

Run by

Sprout Pharmaceuticals, Inc

People needed

1090

Starts

2009-10-01

Expected to finish

2011-02-01

Last updated by the study team

2014-05-19

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 511.147.01046 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 511.147.01042 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 511.147.01025 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 511.147.01073 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 511.147.01030 Boehringer Ingelheim Investigational Site — Encinitas, California, United States
• 511.147.01028 Boehringer Ingelheim Investigational Site — Fair Oaks, California, United States
• 511.147.01037 Boehringer Ingelheim Investigational Site — Irvine, California, United States
• 511.147.01022 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 511.147.01035 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.147.01052 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.147.01016 Boehringer Ingelheim Investigational Site — Torrance, California, United States
• 511.147.01021 Boehringer Ingelheim Investigational Site — Vista, California, United States
• 511.147.01051 Boehringer Ingelheim Investigational Site — Westlake Village, California, United States
• 511.147.01071 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 511.147.01053 Boehringer Ingelheim Investigational Site — Farmington, Connecticut, United States
• 511.147.01015 Boehringer Ingelheim Investigational Site — Groton, Connecticut, United States
• 511.147.01041 Boehringer Ingelheim Investigational Site — New Britain, Connecticut, United States
• 511.147.01064 Boehringer Ingelheim Investigational Site — Newark, Delaware, United States
• 511.147.01062 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 511.147.01003 Boehringer Ingelheim Investigational Site — Boynton Beach, Florida, United States
• 511.147.01056 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 511.147.01065 Boehringer Ingelheim Investigational Site — Daytona Beach, Florida, United States
• 511.147.01020 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 511.147.01024 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 511.147.01074 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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