Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women
Sexual Dysfunctions, Psychological
About this trial
This is an interventional treatment trial for Sexual Dysfunctions, Psychological
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- 511.74.01051 Boehringer Ingelheim Investigational Site
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- 511.74.01029 Boehringer Ingelheim Investigational Site
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- 511.74.01049 Boehringer Ingelheim Investigational Site
- 511.74.02011 Boehringer Ingelheim Investigational Site
- 511.74.02009 Boehringer Ingelheim Investigational Site
- 511.74.02012 Boehringer Ingelheim Investigational Site
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- 511.74.02008 Boehringer Ingelheim Investigational Site