A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
- Registration Number
- NCT00441558
- Lead Sponsor
- Sprout Pharmaceuticals, Inc
- 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) with Flibanserin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 1723
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description flibanserin Flibanserin flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
- Primary Outcome Measures
Name Time Method The Frequency of Adverse Events (Side Effects). 52 weeks This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (196)
511.84.01079 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
511.84.01193 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
511.84.01188 Boehringer Ingelheim Investigational Site
🇺🇸Huntsville, Alabama, United States
511.84.01110 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
511.84.01142 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
511.84.01157 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
511.84.01162 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Alaska, United States
511.84.01070 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
511.84.01191 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
511.84.01115 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
Scroll for more (186 remaining)511.84.01079 Boehringer Ingelheim Investigational Site🇺🇸Birmingham, Alabama, United States