Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

NCT00277914 | Completed Phase 3

• 1 other identifier: 511.74
• Study Type: interventional
• Target: 749
• Locations: 2 countries
• Sites: 65

Brief Summary

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

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• Duration of efficacy of flibanserin in Sexually Satisfying Events

  24 weeks

Interventions

Flibanserin DRUG

flibanserin flexible dosing

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women over 18 and pre-menopausal
• FSDS-R above 14
• Willingness to try to have sexual activity at least monthly
• Willingness to use an electronic diary daily
• Stable, monogamous, heterosexual relationship for at least one year
• Medically acceptable method of contraception

You may not qualify if:

• Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
• Specified medications
• Sexual function affected by medication
• Drug dependence or abuse
• Sexual partner needing treatment
• Peri-Menopause or Menopause (surgical or otherwise)
• Pregnancy
• Pelvic Inflammatory Disease
• Major depressive Episode
• Significant ECG abnormalities
• Significant Neurologic findings
• Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
• Uncorrected thyroid or endocrine disease
• Uncontrolled Glaucoma

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (65)

511.74.01051 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

511.74.01027 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.74.01029 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Location

511.74.01031 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

511.74.01004 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Location

511.74.01053 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

511.74.01033 Boehringer Ingelheim Investigational Site

Palm Springs, California, United States

Location

511.74.01003 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Location

511.74.01015 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

511.74.01013 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.74.01052 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

511.74.01022 Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Location

511.74.01046 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.74.01002 Boehringer Ingelheim Investigational Site

Groton, Connecticut, United States

Location

511.74.01023 Boehringer Ingelheim Investigational Site

Middlebury, Connecticut, United States

Location

511.74.01009 Boehringer Ingelheim Investigational Site

West Hartford, Connecticut, United States

Location

511.74.01035 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

511.74.01039 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

511.74.01019 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Location

511.74.01044 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

511.74.01001 Boehringer Ingelheim Investigational Site

Hudson, Florida, United States

Location

511.74.01043 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

511.74.01032 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

511.74.01036 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

511.74.01047 Boehringer Ingelheim Investigational Site

Champaign, Illinois, United States

Location

511.74.01038 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

511.74.01014 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

511.74.01007 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

511.74.01024 Boehringer Ingelheim Investigational Site

Rockland, Maine, United States

Location

511.74.01030 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

511.74.01056 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Location

511.74.01010 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

511.74.01012 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Location

511.74.01045 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

511.74.01041 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

511.74.01055 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Location

511.74.01018 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Location

511.74.01011 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

511.74.01048 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

511.74.01021 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.74.01042 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

511.74.01050 Boehringer Ingelheim Investigational Site

Edmond, Oklahoma, United States

Location

511.74.01006 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

511.74.01034 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

511.74.01040 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

511.74.01017 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Location

511.74.01057 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Location

511.74.01008 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

511.74.01016 Boehringer Ingelheim Investigational Site

Plano, Texas, United States

Location

511.74.01020 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.74.01005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

511.74.01026 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

511.74.01037 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

511.74.01028 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

511.74.01049 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

511.74.02011 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Location

511.74.02009 Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, Canada

Location

511.74.02012 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

511.74.02006 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

511.74.02004 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

511.74.02010 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Location

511.74.02003 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Location

511.74.02002 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

511.74.02007 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

511.74.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: January 1, 2006
• Primary Completion: July 1, 2007
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

CA (10); US (55)