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A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441558
Recruitment Status : Terminated (terminated for administrative reasons)
First Posted : March 1, 2007
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunctions, Psychological Drug: Flibanserin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1723 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD
Study Start Date : February 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: flibanserin
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Drug: Flibanserin
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
  2. 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.
  3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
  4. 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:

  1. 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.
  2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
  3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  4. Patients who are pregnant or have been pregnant within 1 month prior to study start.
  5. 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.
  6. Clinically significant ECG or lab abnormalities at study start.
  7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441558

  Show 196 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sprout Pharmaceuticals, Inc Identifier: NCT00441558     History of Changes
Other Study ID Numbers: 511.84
First Posted: March 1, 2007    Key Record Dates
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders