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Flibanserin Randomized Withdrawal Trial in Pre-Menopausal Women
This study has been completed.
First Received: January 16, 2006   Last Updated: December 16, 2008   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00277914
  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 III

Study Type: Interventional
Study Design: Treatment
Official Title: 12-Month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Resource links provided by NLM:

MedlinePlus related topics: Female Sexual Dysfunction
Drug Information available for: Flibanserin
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 749
Study Start Date: January 2006
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  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

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

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 511.74
Study First Received: January 16, 2006
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00277914     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009



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