Status:
COMPLETED
Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women
Lead Sponsor:
Sprout Pharmaceuticals, Inc
Conditions:
Sexual Dysfunctions, Psychological
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
749 Patients enrolled
Trial Details
Trial ID
NCT00277914
Start Date
January 1 2006
Last Update
March 16 2012
Active Locations (65)
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1
511.74.01051 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
511.74.01027 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
3
511.74.01029 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona, United States
4
511.74.01031 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States