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Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

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: NCT00277914
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 749 participants
Allocation: N/A
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
Study Start Date : January 2006
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Intervention Details:
  • Drug: Flibanserin
    flibanserin flexible dosing

Primary Outcome Measures :
  1. Duration of efficacy of flibanserin in Sexually Satisfying Events [ Time Frame: 24 weeks ]

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

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

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): NCT00277914

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Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Sprout Pharmaceuticals, Inc Identifier: NCT00277914    
Other Study ID Numbers: 511.74
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Mental Disorders