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6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
This study has been completed.
First Received: August 3, 2006   Last Updated: April 24, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00360243
  Purpose

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.


Condition Intervention Phase
Sexual Dysfunctions, Psychological
Drug: flibanserin
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: 6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • change from baseline in the frequency of satisfying sexual events as measured by the eDiary and the change from baseline in the monthly sum of responses to the eDiary daily desire question (Week 21 to 24). [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • FSDS R© which quantifies the change in personal distress due to sexual dysfunction. [ Time Frame: 24 weeks ]

Enrollment: 1392
Study Start Date: July 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women who are 18 years of age and older.
  2. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
  3. Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
  4. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
  5. Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
  6. At the Baseline Visit, patients must have complied with eDiary use adequately.
  7. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
  8. Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
  9. In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
  10. Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
  11. Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

  1. Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
  2. Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
  3. Patients with a history of drug dependence or abuse within the past one year.
  4. Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
  5. Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
  6. Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
  7. Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
  8. Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
  9. Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
  10. Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
  11. Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360243

  Hide Study Locations
Locations
United States, Alabama
511.70.01068 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
511.70.01040 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
United States, Arizona
511.70.01041 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
United States, Arkansas
511.70.01003 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas, United States
United States, California
511.70.01066 Boehringer Ingelheim Investigational Site
Walnut Creek, California, United States
511.70.01014 Boehringer Ingelheim Investigational Site
Stanford, California, United States
511.70.01072 Boehringer Ingelheim Investigational Site
Torrance, California, United States
511.70.01078 Boehringer Ingelheim Investigational Site
Vista, California, United States
511.70.01017 Boehringer Ingelheim Investigational Site
Tarzana, California, United States
511.70.01070 Boehringer Ingelheim Investigational Site
Carmichael, California, United States
511.70.01015 Boehringer Ingelheim Investigational Site
San Diego, California, United States
511.70.01026 Boehringer Ingelheim Investigational Site
Redding, California, United States
United States, Colorado
511.70.01064 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
511.70.01001 Boehringer Ingelheim Investigational Site
Wheatridge, Colorado, United States
United States, Connecticut
511.70.01006 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
511.70.01050 Boehringer Ingelheim Investigational Site
Farmington, Connecticut, United States
511.70.01055 Boehringer Ingelheim Investigational Site
New London, Connecticut, United States
United States, Florida
511.70.01062 Boehringer Ingelheim Investigational Site
New Port Richey, Florida, United States
511.70.01063 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
511.70.01084 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
511.70.01085 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
511.70.01027 Boehringer Ingelheim Investigational Site
Gainesville, Florida, United States
511.70.01042 Boehringer Ingelheim Investigational Site
Stuart, Florida, United States
511.70.01043 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
511.70.01086 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
511.70.01048 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
511.70.01056 Boehringer Ingelheim Investigational Site
Daytona Beach, Florida, United States
511.70.01024 Boehringer Ingelheim Investigational Site
Aventura, Florida, United States
511.70.01090 Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States
United States, Georgia
511.70.01087 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
511.70.01022 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
511.70.01052 Boehringer Ingelheim Investigational Site
Roswell, Georgia, United States
511.70.01057 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
United States, Illinois
511.70.01058 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
511.70.01060 Boehringer Ingelheim Investigational Site
Champaign, Illinois, United States
United States, Indiana
511.70.01032 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
United States, Kentucky
511.70.01018 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
United States, Louisiana
511.70.01079 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
511.70.01007 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
511.70.01047 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Maryland
511.70.01031 Boehringer Ingelheim Investigational Site
St. Louis, Maryland, United States
United States, Massachusetts
511.70.01011 Boehringer Ingelheim Investigational Site
Haverhill, Massachusetts, United States
United States, Michigan
511.70.01081 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
511.70.01028 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Montana
511.70.01082 Boehringer Ingelheim Investigational Site
Billings, Montana, United States
United States, New Jersey
511.70.01077 Boehringer Ingelheim Investigational Site
Moorestown, New Jersey, United States
United States, New York
511.70.01067 Boehringer Ingelheim Investigational Site
Purchase, New York, United States
511.70.01076 Boehringer Ingelheim Investigational Site
New York, New York, United States
511.70.01019 Boehringer Ingelheim Investigational Site
Endwell, New York, United States
511.70.01025 Boehringer Ingelheim Investigational Site
Poughkeepsie, New York, United States
United States, North Carolina
511.70.01016 Boehringer Ingelheim Investigational Site
Mount Airy, North Carolina, United States
511.70.01044 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
United States, Ohio
511.70.01089 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
511.70.01075 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
511.70.01049 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
511.70.01054 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
511.70.01002 Boehringer Ingelheim Investigational Site
Mayfield Heights, Ohio, United States
United States, Oklahoma
511.70.01065 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
511.70.01083 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
United States, Oregon
511.70.01036 Boehringer Ingelheim Investigational Site
Medford, Oregon, United States
United States, Pennsylvania
511.70.01021 Boehringer Ingelheim Investigational Site
West Reading, Pennsylvania, United States
511.70.01004 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Rhode Island
511.70.01073 Boehringer Ingelheim Investigational Site
Warwick, Rhode Island, United States
United States, South Carolina
511.70.01023 Boehringer Ingelheim Investigational Site
Anderson, South Carolina, United States
511.70.01035 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Tennessee
511.70.01008 Boehringer Ingelheim Investigational Site
Nasville, Tennessee, United States
United States, Texas
511.70.01020 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas, United States
511.70.01009 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
511.70.01013 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
511.70.01030 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
511.70.01091 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Utah
511.70.01061 Boehringer Ingelheim Investigational Site
Sandy, Utah, United States
511.70.01005 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Vermont
511.70.01010 Boehringer Ingelheim Investigational Site
Burlington, Vermont, United States
United States, Virginia
511.70.01071 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
511.70.01012 Boehringer Ingelheim Investigational Site
Charlottesville, Virginia, United States
511.70.01029 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
511.70.01046 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
United States, Washington
511.70.01033 Boehringer Ingelheim Investigational Site
Bellevue, Washington, United States
511.70.01039 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
United States, Wisconsin
511.70.01069 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
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: 511.70
Study First Received: August 3, 2006
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00360243     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