NCT00441558TerminatedPhase 3
Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD
Sprout Pharmaceuticals, Inc196 sites in 1 country1,723 target enrollmentStarted: February 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Sprout Pharmaceuticals, Inc
- Enrollment
- 1,723
- Locations
- 196
- Primary Endpoint
- The Frequency of Adverse Events (Side Effects).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
flibanserin
Experimental
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Intervention: Flibanserin (Drug)
Outcomes
Primary Outcomes
The Frequency of Adverse Events (Side Effects).
Time Frame: 52 weeks
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (196)
Loading locations...
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