Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

March 14, 2012 updated by: Sprout Pharmaceuticals, Inc

12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

749

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • 511.74.02011 Boehringer Ingelheim Investigational Site
      • Kelowna, British Columbia, Canada
        • 511.74.02009 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 511.74.02012 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 511.74.02006 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 511.74.02004 Boehringer Ingelheim Investigational Site
    • Ontario
      • Kingston, Ontario, Canada
        • 511.74.02010 Boehringer Ingelheim Investigational Site
      • Oakville, Ontario, Canada
        • 511.74.02003 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 511.74.02002 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 511.74.02007 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 511.74.02008 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 511.74.01051 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 511.74.01027 Boehringer Ingelheim Investigational Site
    • Arizona
      • Scottsdale, Arizona, United States
        • 511.74.01029 Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • 511.74.01031 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • 511.74.01004 Boehringer Ingelheim Investigational Site
      • Little Rock, Arkansas, United States
        • 511.74.01053 Boehringer Ingelheim Investigational Site
    • California
      • Palm Springs, California, United States
        • 511.74.01033 Boehringer Ingelheim Investigational Site
      • Palo Alto, California, United States
        • 511.74.01003 Boehringer Ingelheim Investigational Site
      • Sacramento, California, United States
        • 511.74.01015 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.74.01013 Boehringer Ingelheim Investigational Site
      • Torrance, California, United States
        • 511.74.01052 Boehringer Ingelheim Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • 511.74.01022 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 511.74.01046 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Groton, Connecticut, United States
        • 511.74.01002 Boehringer Ingelheim Investigational Site
      • Middlebury, Connecticut, United States
        • 511.74.01023 Boehringer Ingelheim Investigational Site
      • West Hartford, Connecticut, United States
        • 511.74.01009 Boehringer Ingelheim Investigational Site
    • Delaware
      • Newark, Delaware, United States
        • 511.74.01035 Boehringer Ingelheim Investigational Site
    • Florida
      • Coral Gables, Florida, United States
        • 511.74.01039 Boehringer Ingelheim Investigational Site
      • Gainesville, Florida, United States
        • 511.74.01019 Boehringer Ingelheim Investigational Site
      • Hollywood, Florida, United States
        • 511.74.01044 Boehringer Ingelheim Investigational Site
      • Hudson, Florida, United States
        • 511.74.01001 Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • 511.74.01043 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 511.74.01032 Boehringer Ingelheim Investigational Site
    • Georgia
      • Roswell, Georgia, United States
        • 511.74.01036 Boehringer Ingelheim Investigational Site
    • Illinois
      • Champaign, Illinois, United States
        • 511.74.01047 Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • 511.74.01038 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 511.74.01014 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • 511.74.01007 Boehringer Ingelheim Investigational Site
    • Maine
      • Rockland, Maine, United States
        • 511.74.01024 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • 511.74.01030 Boehringer Ingelheim Investigational Site
      • Bingham Farms, Michigan, United States
        • 511.74.01056 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 511.74.01010 Boehringer Ingelheim Investigational Site
    • Montana
      • Billings, Montana, United States
        • 511.74.01012 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 511.74.01045 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 511.74.01041 Boehringer Ingelheim Investigational Site
      • Reno, Nevada, United States
        • 511.74.01055 Boehringer Ingelheim Investigational Site
    • New York
      • Poughkeepsie, New York, United States
        • 511.74.01018 Boehringer Ingelheim Investigational Site
      • Rochester, New York, United States
        • 511.74.01011 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • 511.74.01048 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 511.74.01021 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 511.74.01042 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Edmond, Oklahoma, United States
        • 511.74.01050 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 511.74.01006 Boehringer Ingelheim Investigational Site
      • Medford, Oregon, United States
        • 511.74.01034 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 511.74.01040 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States
        • 511.74.01017 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • 511.74.01057 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, United States
        • 511.74.01008 Boehringer Ingelheim Investigational Site
    • Texas
      • Plano, Texas, United States
        • 511.74.01016 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.74.01020 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 511.74.01005 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 511.74.01026 Boehringer Ingelheim Investigational Site
    • Washington
      • Renton, Washington, United States
        • 511.74.01037 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 511.74.01028 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 511.74.01049 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of efficacy of flibanserin in Sexually Satisfying Events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sprout Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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