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

This study has been terminated.
(terminated for administrative reasons)
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc Identifier:
First received: February 28, 2007
Last updated: May 14, 2014
Last verified: May 2014
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 Intervention Phase
Sexual Dysfunctions, Psychological Drug: Flibanserin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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

Enrollment: 1723
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00441558

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

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
Study First Received: February 28, 2007
Results First Received: May 14, 2014
Last Updated: May 14, 2014

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders processed this record on September 21, 2017