Clinical trial NCT00277914: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2006-01-18
Enrollment: 749
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Duration of efficacy of flibanserin in Sexually Satisfying Events
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 511.74.01051 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 511.74.01027 Boehringer Ingelheim Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: 511.74.01029 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 511.74.01031 Boehringer Ingelheim Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: 511.74.01004 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: 511.74.01053 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Palm Springs
country: United States
facility: 511.74.01033 Boehringer Ingelheim Investigational Site
state: California
city: Palo Alto
country: United States
facility: 511.74.01003 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 511.74.01015 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.74.01013 Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: 511.74.01052 Boehringer Ingelheim Investigational Site
state: California
city: Aurora
country: United States
facility: 511.74.01022 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 511.74.01046 Boehringer Ingelheim Investigational Site
state: Colorado
city: Groton
country: United States
facility: 511.74.01002 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Middlebury
country: United States
facility: 511.74.01023 Boehringer Ingelheim Investigational Site
state: Connecticut
city: West Hartford
country: United States
facility: 511.74.01009 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 511.74.01035 Boehringer Ingelheim Investigational Site
state: Delaware
city: Coral Gables
country: United States
facility: 511.74.01039 Boehringer Ingelheim Investigational Site
state: Florida
city: Gainesville
country: United States
facility: 511.74.01019 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 511.74.01044 Boehringer Ingelheim Investigational Site
state: Florida
city: Hudson
country: United States
facility: 511.74.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 511.74.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 511.74.01032 Boehringer Ingelheim Investigational Site
state: Florida
city: Roswell
country: United States
facility: 511.74.01036 Boehringer Ingelheim Investigational Site
state: Georgia
city: Champaign
country: United States
facility: 511.74.01047 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: 511.74.01038 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lexington
country: United States
facility: 511.74.01014 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: 511.74.01007 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Rockland
country: United States
facility: 511.74.01024 Boehringer Ingelheim Investigational Site
state: Maine
city: Ann Arbor
country: United States
facility: 511.74.01030 Boehringer Ingelheim Investigational Site
state: Michigan
city: Bingham Farms
country: United States
facility: 511.74.01056 Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: 511.74.01010 Boehringer Ingelheim Investigational Site
state: Missouri
city: Billings
country: United States
facility: 511.74.01012 Boehringer Ingelheim Investigational Site
state: Montana
city: Omaha
country: United States
facility: 511.74.01045 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: 511.74.01041 Boehringer Ingelheim Investigational Site
state: Nevada
city: Reno
country: United States
facility: 511.74.01055 Boehringer Ingelheim Investigational Site
state: Nevada
city: Poughkeepsie
country: United States
facility: 511.74.01018 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 511.74.01011 Boehringer Ingelheim Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: 511.74.01048 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 511.74.01021 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.74.01042 Boehringer Ingelheim Investigational Site
state: Ohio
city: Edmond
country: United States
facility: 511.74.01050 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 511.74.01006 Boehringer Ingelheim Investigational Site
state: Oregon
city: Medford
country: United States
facility: 511.74.01034 Boehringer Ingelheim Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: 511.74.01040 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: 511.74.01017 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: 511.74.01057 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.74.01008 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Plano
country: United States
facility: 511.74.01016 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.74.01020 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 511.74.01005 Boehringer Ingelheim Investigational Site
state: Utah
city: Norfolk
country: United States
facility: 511.74.01026 Boehringer Ingelheim Investigational Site
state: Virginia
city: Renton
country: United States
facility: 511.74.01037 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 511.74.01028 Boehringer Ingelheim Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: 511.74.01049 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Coquitlam
country: Canada
facility: 511.74.02011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: 511.74.02009 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 511.74.02012 Boehringer Ingelheim Investigational Site
state: Manitoba
city: St. John's
country: Canada
facility: 511.74.02006 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: 511.74.02004 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: 511.74.02010 Boehringer Ingelheim Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: 511.74.02003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 511.74.02002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 511.74.02007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 511.74.02008 Boehringer Ingelheim Investigational Site
state: Quebec
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: