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Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00277914
First Posted: January 18, 2006
Last Update Posted: March 16, 2012
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.
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00277914


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

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00277914     History of Changes
Other Study ID Numbers: 511.74
First Submitted: January 16, 2006
First Posted: January 18, 2006
Last Update Posted: March 16, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders


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