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Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Flibanserin
Sponsored by
Sprout Pharmaceuticals, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions, Psychological

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • 511.74.01051 Boehringer Ingelheim Investigational Site
  • 511.74.01027 Boehringer Ingelheim Investigational Site
  • 511.74.01029 Boehringer Ingelheim Investigational Site
  • 511.74.01031 Boehringer Ingelheim Investigational Site
  • 511.74.01004 Boehringer Ingelheim Investigational Site
  • 511.74.01053 Boehringer Ingelheim Investigational Site
  • 511.74.01033 Boehringer Ingelheim Investigational Site
  • 511.74.01003 Boehringer Ingelheim Investigational Site
  • 511.74.01015 Boehringer Ingelheim Investigational Site
  • 511.74.01013 Boehringer Ingelheim Investigational Site
  • 511.74.01052 Boehringer Ingelheim Investigational Site
  • 511.74.01022 Boehringer Ingelheim Investigational Site
  • 511.74.01046 Boehringer Ingelheim Investigational Site
  • 511.74.01002 Boehringer Ingelheim Investigational Site
  • 511.74.01023 Boehringer Ingelheim Investigational Site
  • 511.74.01009 Boehringer Ingelheim Investigational Site
  • 511.74.01035 Boehringer Ingelheim Investigational Site
  • 511.74.01039 Boehringer Ingelheim Investigational Site
  • 511.74.01019 Boehringer Ingelheim Investigational Site
  • 511.74.01044 Boehringer Ingelheim Investigational Site
  • 511.74.01001 Boehringer Ingelheim Investigational Site
  • 511.74.01043 Boehringer Ingelheim Investigational Site
  • 511.74.01032 Boehringer Ingelheim Investigational Site
  • 511.74.01036 Boehringer Ingelheim Investigational Site
  • 511.74.01047 Boehringer Ingelheim Investigational Site
  • 511.74.01038 Boehringer Ingelheim Investigational Site
  • 511.74.01014 Boehringer Ingelheim Investigational Site
  • 511.74.01007 Boehringer Ingelheim Investigational Site
  • 511.74.01024 Boehringer Ingelheim Investigational Site
  • 511.74.01030 Boehringer Ingelheim Investigational Site
  • 511.74.01056 Boehringer Ingelheim Investigational Site
  • 511.74.01010 Boehringer Ingelheim Investigational Site
  • 511.74.01012 Boehringer Ingelheim Investigational Site
  • 511.74.01045 Boehringer Ingelheim Investigational Site
  • 511.74.01041 Boehringer Ingelheim Investigational Site
  • 511.74.01055 Boehringer Ingelheim Investigational Site
  • 511.74.01018 Boehringer Ingelheim Investigational Site
  • 511.74.01011 Boehringer Ingelheim Investigational Site
  • 511.74.01048 Boehringer Ingelheim Investigational Site
  • 511.74.01021 Boehringer Ingelheim Investigational Site
  • 511.74.01042 Boehringer Ingelheim Investigational Site
  • 511.74.01050 Boehringer Ingelheim Investigational Site
  • 511.74.01006 Boehringer Ingelheim Investigational Site
  • 511.74.01034 Boehringer Ingelheim Investigational Site
  • 511.74.01040 Boehringer Ingelheim Investigational Site
  • 511.74.01017 Boehringer Ingelheim Investigational Site
  • 511.74.01057 Boehringer Ingelheim Investigational Site
  • 511.74.01008 Boehringer Ingelheim Investigational Site
  • 511.74.01016 Boehringer Ingelheim Investigational Site
  • 511.74.01020 Boehringer Ingelheim Investigational Site
  • 511.74.01005 Boehringer Ingelheim Investigational Site
  • 511.74.01026 Boehringer Ingelheim Investigational Site
  • 511.74.01037 Boehringer Ingelheim Investigational Site
  • 511.74.01028 Boehringer Ingelheim Investigational Site
  • 511.74.01049 Boehringer Ingelheim Investigational Site
  • 511.74.02011 Boehringer Ingelheim Investigational Site
  • 511.74.02009 Boehringer Ingelheim Investigational Site
  • 511.74.02012 Boehringer Ingelheim Investigational Site
  • 511.74.02006 Boehringer Ingelheim Investigational Site
  • 511.74.02004 Boehringer Ingelheim Investigational Site
  • 511.74.02010 Boehringer Ingelheim Investigational Site
  • 511.74.02003 Boehringer Ingelheim Investigational Site
  • 511.74.02002 Boehringer Ingelheim Investigational Site
  • 511.74.02007 Boehringer Ingelheim Investigational Site
  • 511.74.02008 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Duration of efficacy of flibanserin in Sexually Satisfying Events

Secondary Outcome Measures

Full Information

First Posted
January 16, 2006
Last Updated
March 14, 2012
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00277914
Brief Title
Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women
Official Title
12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sprout Pharmaceuticals, Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
749 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Flibanserin
Intervention Description
flibanserin flexible dosing
Primary Outcome Measure Information:
Title
Duration of efficacy of flibanserin in Sexually Satisfying Events
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
511.74.01051 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
511.74.01027 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
511.74.01029 Boehringer Ingelheim Investigational Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
511.74.01031 Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
511.74.01004 Boehringer Ingelheim Investigational Site
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
511.74.01053 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
511.74.01033 Boehringer Ingelheim Investigational Site
City
Palm Springs
State/Province
California
Country
United States
Facility Name
511.74.01003 Boehringer Ingelheim Investigational Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
511.74.01015 Boehringer Ingelheim Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
511.74.01013 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
511.74.01052 Boehringer Ingelheim Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
511.74.01022 Boehringer Ingelheim Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
511.74.01046 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
511.74.01002 Boehringer Ingelheim Investigational Site
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
511.74.01023 Boehringer Ingelheim Investigational Site
City
Middlebury
State/Province
Connecticut
Country
United States
Facility Name
511.74.01009 Boehringer Ingelheim Investigational Site
City
West Hartford
State/Province
Connecticut
Country
United States
Facility Name
511.74.01035 Boehringer Ingelheim Investigational Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
511.74.01039 Boehringer Ingelheim Investigational Site
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
511.74.01019 Boehringer Ingelheim Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
511.74.01044 Boehringer Ingelheim Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
511.74.01001 Boehringer Ingelheim Investigational Site
City
Hudson
State/Province
Florida
Country
United States
Facility Name
511.74.01043 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
511.74.01032 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
511.74.01036 Boehringer Ingelheim Investigational Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
511.74.01047 Boehringer Ingelheim Investigational Site
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
511.74.01038 Boehringer Ingelheim Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
511.74.01014 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
511.74.01007 Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
511.74.01024 Boehringer Ingelheim Investigational Site
City
Rockland
State/Province
Maine
Country
United States
Facility Name
511.74.01030 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
511.74.01056 Boehringer Ingelheim Investigational Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
511.74.01010 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
511.74.01012 Boehringer Ingelheim Investigational Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
511.74.01045 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
511.74.01041 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
511.74.01055 Boehringer Ingelheim Investigational Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
511.74.01018 Boehringer Ingelheim Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
511.74.01011 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
511.74.01048 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
511.74.01021 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
511.74.01042 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
511.74.01050 Boehringer Ingelheim Investigational Site
City
Edmond
State/Province
Oklahoma
Country
United States
Facility Name
511.74.01006 Boehringer Ingelheim Investigational Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
511.74.01034 Boehringer Ingelheim Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
511.74.01040 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
511.74.01017 Boehringer Ingelheim Investigational Site
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
511.74.01057 Boehringer Ingelheim Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
511.74.01008 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
511.74.01016 Boehringer Ingelheim Investigational Site
City
Plano
State/Province
Texas
Country
United States
Facility Name
511.74.01020 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
511.74.01005 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
511.74.01026 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
511.74.01037 Boehringer Ingelheim Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
511.74.01028 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
511.74.01049 Boehringer Ingelheim Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
511.74.02011 Boehringer Ingelheim Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
511.74.02009 Boehringer Ingelheim Investigational Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
511.74.02012 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
511.74.02006 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
511.74.02004 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
511.74.02010 Boehringer Ingelheim Investigational Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
511.74.02003 Boehringer Ingelheim Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
511.74.02002 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.74.02007 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
511.74.02008 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

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