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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 completed.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00441558
First received: February 28, 2007
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The frequency of adverse events (side effects). [ Time Frame: This is a 52-week, OL trial assessing safety/tolerability of flibanserin in women w. Hypoactive Sexual Desire Disorder ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinically significant changes to physical exam, pelvic exam, vital signs, ECG, labs, eye exams, and overall patient status. Additionally, patients must complete questionnaires related to sexual health, depression and suicidal thoughts. [ Time Frame: This is a 52-week, OL trial assessing safety/tolerability of flibanserin in women w. Hypoactive Sexual Desire Disorder ] [ Designated as safety issue: Yes ]

Enrollment: 1767
Study Start Date: February 2007
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Flibanserin
    flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with a primary diagnosis of HSDD who have completed a previous study(511.70/.71/.74/.75/.105) with 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 parenting pressure, eldercare, 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.
  7. LFTs 2 X ULN, BUN, hematology labs, fasting glucose criterial per protocol
  8. exclusionary con meds per protocol and amendment #1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441558

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

No publications provided by Sprout Pharmaceuticals, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00441558     History of Changes
Other Study ID Numbers: 511.84
Study First Received: February 28, 2007
Last Updated: March 14, 2012
Health Authority: Canada: Health Canada (TPD)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013