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

Stopped early · 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

NCT01057901

Run by

Sprout Pharmaceuticals, Inc

People needed

748

Starts

2010-01-01

Expected to finish

2011-01-01

Last updated by the study team

2014-06-17

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

• 511.156.01084 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 511.156.01053 Boehringer Ingelheim Investigational Site — Tuscon, Arizona, United States
• 511.156.01069 Boehringer Ingelheim Investigational Site — Tuscon, Arizona, United States
• 511.156.01063 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 511.156.01076 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 511.156.01039 Boehringer Ingelheim Investigational Site — Anaheim, California, United States
• 511.156.01070 Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• 511.156.01075 Boehringer Ingelheim Investigational Site — La Mesa, California, United States
• 511.156.01087 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 511.156.01064 Boehringer Ingelheim Investigational Site — Newport Beach, California, United States
• 511.156.01016 Boehringer Ingelheim Investigational Site — Oceanside, California, United States
• 511.156.01007 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.156.01038 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.156.01067 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
• 511.156.01036 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 511.156.01092 Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, United States
• 511.156.01027 Boehringer Ingelheim Investigational Site — New London, Connecticut, United States
• 511.156.01022 Boehringer Ingelheim Investigational Site — Coral Gables, Florida, United States
• 511.156.01042 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 511.156.01047 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 511.156.01051 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 511.156.01011 Boehringer Ingelheim Investigational Site — Gainseville, Florida, United States
• 511.156.01078 Boehringer Ingelheim Investigational Site — Lake Worth, Florida, United States
• 511.156.01095 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 511.156.01059 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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