Status:
TERMINATED
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
Lead Sponsor:
Sprout Pharmaceuticals, Inc
Conditions:
Sexual Dysfunctions, Psychological
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
Brief Summary
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) wi...
Eligibility Criteria
Inclusion
- Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
- Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
- Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
- Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.
Exclusion
- A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
- Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
- Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
- Patients who are pregnant or have been pregnant within 1 month prior to study start.
- Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
- Clinically significant ECG or lab abnormalities at study start.
- Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1723 Patients enrolled
Trial Details
Trial ID
NCT00441558
Start Date
February 1 2007
End Date
August 1 2009
Last Update
June 13 2014
Active Locations (196)
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1
511.84.01079 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
511.84.01193 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
3
511.84.01188 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
4
511.84.01110 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States