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Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00277914
First received: January 16, 2006
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.


Condition Intervention Phase
Sexual Dysfunctions, Psychological
 Drug: Flibanserin
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Duration of efficacy of flibanserin in Sexually Satisfying Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 749
Study Start Date: January 2006
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Flibanserin
    flibanserin flexible dosing
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women over 18 and pre-menopausal
  2. FSDS-R above 14
  3. Willingness to try to have sexual activity at least monthly
  4. Willingness to use an electronic diary daily
  5. Stable, monogamous, heterosexual relationship for at least one year
  6. Medically acceptable method of contraception

Exclusion Criteria:

  1. Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
  2. Specified medications
  3. Sexual function affected by medication
  4. Drug dependence or abuse
  5. Sexual partner needing treatment
  6. Peri-Menopause or Menopause (surgical or otherwise)
  7. Pregnancy
  8. Pelvic Inflammatory Disease
  9. Major depressive Episode
  10. Significant ECG abnormalities
  11. Significant Neurologic findings
  12. Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
  13. Uncorrected thyroid or endocrine disease
  14. Uncontrolled Glaucoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277914

  Show 65 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00277914     History of Changes
Other Study ID Numbers: 511.74
Study First Received: January 16, 2006
Last Updated: March 14, 2012
Health Authority: 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 16, 2013