Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Completed · Phase 3

Conditions studied: Sexual Dysfunctions, Psychological

In brief

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

Key facts

Study ID

NCT00277914

Run by

Sprout Pharmaceuticals, Inc

People needed

749

Starts

2006-01-01

Last updated by the study team

2012-03-16

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 511.74.01027 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 511.74.01029 Boehringer Ingelheim Investigational Site — Scottsdale, Arizona, United States
• 511.74.01031 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 511.74.01004 Boehringer Ingelheim Investigational Site — Jonesboro, Arkansas, United States
• 511.74.01053 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 511.74.01033 Boehringer Ingelheim Investigational Site — Palm Springs, California, United States
• 511.74.01003 Boehringer Ingelheim Investigational Site — Palo Alto, California, United States
• 511.74.01015 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 511.74.01013 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 511.74.01052 Boehringer Ingelheim Investigational Site — Torrance, California, United States
• 511.74.01022 Boehringer Ingelheim Investigational Site — Aurora, Colorado, United States
• 511.74.01046 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 511.74.01002 Boehringer Ingelheim Investigational Site — Groton, Connecticut, United States
• 511.74.01023 Boehringer Ingelheim Investigational Site — Middlebury, Connecticut, United States
• 511.74.01009 Boehringer Ingelheim Investigational Site — West Hartford, Connecticut, United States
• 511.74.01035 Boehringer Ingelheim Investigational Site — Newark, Delaware, United States
• 511.74.01039 Boehringer Ingelheim Investigational Site — Coral Gables, Florida, United States
• 511.74.01019 Boehringer Ingelheim Investigational Site — Gainesville, Florida, United States
• 511.74.01044 Boehringer Ingelheim Investigational Site — Hollywood, Florida, United States
• 511.74.01001 Boehringer Ingelheim Investigational Site — Hudson, Florida, United States
• 511.74.01043 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• 511.74.01032 Boehringer Ingelheim Investigational Site — St. Petersburg, Florida, United States
• 511.74.01036 Boehringer Ingelheim Investigational Site — Roswell, Georgia, United States
• 511.74.01047 Boehringer Ingelheim Investigational Site — Champaign, Illinois, United States
• 511.74.01051 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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