Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women
- Conditions
- Sexual Dysfunctions, Psychological
- Registration Number
- NCT00277914
- Lead Sponsor
- Sprout Pharmaceuticals, Inc
- Brief Summary
To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 749
- Women over 18 and pre-menopausal
- FSDS-R above 14
- Willingness to try to have sexual activity at least monthly
- Willingness to use an electronic diary daily
- Stable, monogamous, heterosexual relationship for at least one year
- Medically acceptable method of contraception
- Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
- Specified medications
- Sexual function affected by medication
- Drug dependence or abuse
- Sexual partner needing treatment
- Peri-Menopause or Menopause (surgical or otherwise)
- Pregnancy
- Pelvic Inflammatory Disease
- Major depressive Episode
- Significant ECG abnormalities
- Significant Neurologic findings
- Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
- Uncorrected thyroid or endocrine disease
- Uncontrolled Glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Duration of efficacy of flibanserin in Sexually Satisfying Events 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (65)
511.74.01042 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Ohio, United States
511.74.01041 Boehringer Ingelheim Investigational Site
🇺🇸Las Vegas, Nevada, United States
511.74.01013 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
511.74.01012 Boehringer Ingelheim Investigational Site
🇺🇸Billings, Montana, United States
511.74.02006 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
511.74.01033 Boehringer Ingelheim Investigational Site
🇺🇸Palm Springs, California, United States
511.74.01004 Boehringer Ingelheim Investigational Site
🇺🇸Jonesboro, Arkansas, United States
511.74.01001 Boehringer Ingelheim Investigational Site
🇺🇸Hudson, Florida, United States
511.74.01047 Boehringer Ingelheim Investigational Site
🇺🇸Champaign, Illinois, United States
511.74.01014 Boehringer Ingelheim Investigational Site
🇺🇸Lexington, Kentucky, United States
511.74.01036 Boehringer Ingelheim Investigational Site
🇺🇸Roswell, Georgia, United States
511.74.01038 Boehringer Ingelheim Investigational Site
🇺🇸Evansville, Indiana, United States
511.74.01024 Boehringer Ingelheim Investigational Site
🇺🇸Rockland, Maine, United States
511.74.01021 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
511.74.02004 Boehringer Ingelheim Investigational Site
🇨🇦Halifax, Nova Scotia, Canada
511.74.02011 Boehringer Ingelheim Investigational Site
🇨🇦Coquitlam, British Columbia, Canada
511.74.01034 Boehringer Ingelheim Investigational Site
🇺🇸Medford, Oregon, United States
511.74.01040 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
511.74.01018 Boehringer Ingelheim Investigational Site
🇺🇸Poughkeepsie, New York, United States
511.74.01011 Boehringer Ingelheim Investigational Site
🇺🇸Rochester, New York, United States
511.74.02008 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
511.74.02012 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
511.74.01017 Boehringer Ingelheim Investigational Site
🇺🇸Anderson, South Carolina, United States
511.74.02009 Boehringer Ingelheim Investigational Site
🇨🇦Kelowna, British Columbia, Canada
511.74.02010 Boehringer Ingelheim Investigational Site
🇨🇦Kingston, Ontario, Canada
511.74.02002 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
511.74.02007 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
511.74.01050 Boehringer Ingelheim Investigational Site
🇺🇸Edmond, Oklahoma, United States
511.74.01028 Boehringer Ingelheim Investigational Site
🇺🇸Spokane, Washington, United States
511.74.01006 Boehringer Ingelheim Investigational Site
🇺🇸Eugene, Oregon, United States
511.74.01037 Boehringer Ingelheim Investigational Site
🇺🇸Renton, Washington, United States
511.74.01003 Boehringer Ingelheim Investigational Site
🇺🇸Palo Alto, California, United States
511.74.01029 Boehringer Ingelheim Investigational Site
🇺🇸Scottsdale, Arizona, United States
511.74.01023 Boehringer Ingelheim Investigational Site
🇺🇸Middlebury, Connecticut, United States
511.74.01053 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Arkansas, United States
511.74.01043 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
511.74.01031 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
511.74.01027 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
511.74.01052 Boehringer Ingelheim Investigational Site
🇺🇸Torrance, California, United States
511.74.01039 Boehringer Ingelheim Investigational Site
🇺🇸Coral Gables, Florida, United States
511.74.01035 Boehringer Ingelheim Investigational Site
🇺🇸Newark, Delaware, United States
511.74.01009 Boehringer Ingelheim Investigational Site
🇺🇸West Hartford, Connecticut, United States
511.74.01002 Boehringer Ingelheim Investigational Site
🇺🇸Groton, Connecticut, United States
511.74.01019 Boehringer Ingelheim Investigational Site
🇺🇸Gainesville, Florida, United States
511.74.01044 Boehringer Ingelheim Investigational Site
🇺🇸Hollywood, Florida, United States
511.74.01032 Boehringer Ingelheim Investigational Site
🇺🇸St. Petersburg, Florida, United States
511.74.01007 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
511.74.01056 Boehringer Ingelheim Investigational Site
🇺🇸Bingham Farms, Michigan, United States
511.74.01055 Boehringer Ingelheim Investigational Site
🇺🇸Reno, Nevada, United States
511.74.01016 Boehringer Ingelheim Investigational Site
🇺🇸Plano, Texas, United States
511.74.01026 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
511.74.01057 Boehringer Ingelheim Investigational Site
🇺🇸Knoxville, Tennessee, United States
511.74.01010 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
511.74.02003 Boehringer Ingelheim Investigational Site
🇨🇦Oakville, Ontario, Canada
511.74.01046 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
511.74.01015 Boehringer Ingelheim Investigational Site
🇺🇸Sacramento, California, United States
511.74.01045 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
511.74.01051 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
511.74.01022 Boehringer Ingelheim Investigational Site
🇺🇸Aurora, Colorado, United States
511.74.01048 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
511.74.01008 Boehringer Ingelheim Investigational Site
🇺🇸Nashville, Tennessee, United States
511.74.01030 Boehringer Ingelheim Investigational Site
🇺🇸Ann Arbor, Michigan, United States
511.74.01020 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
511.74.01005 Boehringer Ingelheim Investigational Site
🇺🇸Salt Lake City, Utah, United States
511.74.01049 Boehringer Ingelheim Investigational Site
🇺🇸Milwaukee, Wisconsin, United States