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Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

NCT ID: NCT00277914

Last Updated: 2012-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

749 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Sexual Dysfunctions, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Flibanserin

flibanserin flexible dosing

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sprout Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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511.74.01051 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

511.74.01027 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

511.74.01029 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Site Status

511.74.01031 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Site Status

511.74.01004 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Site Status

511.74.01053 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

511.74.01033 Boehringer Ingelheim Investigational Site

Palm Springs, California, United States

Site Status

511.74.01003 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Site Status

511.74.01015 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Site Status

511.74.01013 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

511.74.01052 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Site Status

511.74.01022 Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Site Status

511.74.01046 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

511.74.01002 Boehringer Ingelheim Investigational Site

Groton, Connecticut, United States

Site Status

511.74.01023 Boehringer Ingelheim Investigational Site

Middlebury, Connecticut, United States

Site Status

511.74.01009 Boehringer Ingelheim Investigational Site

West Hartford, Connecticut, United States

Site Status

511.74.01035 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Site Status

511.74.01039 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Site Status

511.74.01019 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Site Status

511.74.01044 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Site Status

511.74.01001 Boehringer Ingelheim Investigational Site

Hudson, Florida, United States

Site Status

511.74.01043 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

511.74.01032 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Site Status

511.74.01036 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Site Status

511.74.01047 Boehringer Ingelheim Investigational Site

Champaign, Illinois, United States

Site Status

511.74.01038 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Site Status

511.74.01014 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

511.74.01007 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Site Status

511.74.01024 Boehringer Ingelheim Investigational Site

Rockland, Maine, United States

Site Status

511.74.01030 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

511.74.01056 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Site Status

511.74.01010 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

511.74.01012 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Site Status

511.74.01045 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

511.74.01041 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

511.74.01055 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Site Status

511.74.01018 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Site Status

511.74.01011 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

511.74.01048 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

511.74.01021 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

511.74.01042 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

511.74.01050 Boehringer Ingelheim Investigational Site

Edmond, Oklahoma, United States

Site Status

511.74.01006 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Site Status

511.74.01034 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

511.74.01040 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

511.74.01017 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Site Status

511.74.01057 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Site Status

511.74.01008 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Site Status

511.74.01016 Boehringer Ingelheim Investigational Site

Plano, Texas, United States

Site Status

511.74.01020 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

511.74.01005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

511.74.01026 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Site Status

511.74.01037 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Site Status

511.74.01028 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

511.74.01049 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Site Status

511.74.02011 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Site Status

511.74.02009 Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, Canada

Site Status

511.74.02012 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

511.74.02006 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

511.74.02004 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

511.74.02010 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Site Status

511.74.02003 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

511.74.02002 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

511.74.02007 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

511.74.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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511.74

Identifier Type: -

Identifier Source: org_study_id

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