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Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

NCT ID: NCT00996164

Last Updated: 2014-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1090 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-02-28

Brief Summary

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The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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flibanserin 100 mg

flibanserin 100mg po qd

Group Type EXPERIMENTAL

Flibanserin

Intervention Type DRUG

patients will be randomized to flibanserin or placebo in a double-blind manner

Placebo

placebo 1 tab po qd

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

patients will be randomized to flibanserin or placebo in a double-blind manner

Interventions

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Flibanserin

patients will be randomized to flibanserin or placebo in a double-blind manner

Intervention Type DRUG

Placebo

patients will be randomized to flibanserin or placebo in a double-blind manner

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Premenopausal women who are 18 years old and older
2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
3. Stable, monogamous heterosexual relationship for at least one year.
4. Willing to discuss sexual issues.
5. Willing to engage in sexual activity at least once a month
6. Normal pap smear
7. Must use medically acceptable method of contraception
8. Able to comply with daily use of a handheld entry device

Exclusion Criteria

1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
3. Partner with inadequately treated organic or psychosexual dysfunction
4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
5. Sexual function impaired by psychiatric disorder
6. Sexual function impaired by gynecological disorder
7. Major life stress that could impair sexual function
8. Substance abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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511.147.01074 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

511.147.01046 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Site Status

511.147.01042 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

511.147.01025 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

511.147.01073 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

511.147.01030 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Site Status

511.147.01028 Boehringer Ingelheim Investigational Site

Fair Oaks, California, United States

Site Status

511.147.01037 Boehringer Ingelheim Investigational Site

Irvine, California, United States

Site Status

511.147.01022 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Site Status

511.147.01035 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

511.147.01052 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

511.147.01016 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Site Status

511.147.01021 Boehringer Ingelheim Investigational Site

Vista, California, United States

Site Status

511.147.01051 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Site Status

511.147.01071 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

511.147.01053 Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Site Status

511.147.01015 Boehringer Ingelheim Investigational Site

Groton, Connecticut, United States

Site Status

511.147.01041 Boehringer Ingelheim Investigational Site

New Britain, Connecticut, United States

Site Status

511.147.01064 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Site Status

511.147.01062 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Site Status

511.147.01003 Boehringer Ingelheim Investigational Site

Boynton Beach, Florida, United States

Site Status

511.147.01056 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

511.147.01065 Boehringer Ingelheim Investigational Site

Daytona Beach, Florida, United States

Site Status

511.147.01020 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

511.147.01024 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

511.147.01070 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Site Status

511.147.01043 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

511.147.01019 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Site Status

511.147.01061 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

511.147.01066 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

511.147.01001 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Site Status

511.147.01002 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Site Status

511.147.01009 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

511.147.01023 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

511.147.01008 Boehringer Ingelheim Investigational Site

Sandy Springs, Georgia, United States

Site Status

511.147.01044 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

511.147.01034 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

511.147.01067 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Site Status

511.147.01013 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

511.147.01031 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Site Status

511.147.01006 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

511.147.01014 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Site Status

511.147.01060 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

511.147.01057 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

511.147.01039 Boehringer Ingelheim Investigational Site

Moorestown, New Jersey, United States

Site Status

511.147.01017 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Site Status

511.147.01047 Boehringer Ingelheim Investigational Site

New Bern, North Carolina, United States

Site Status

511.147.01027 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

511.147.01033 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

511.147.01004 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

511.147.01050 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

511.147.01059 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

511.147.01058 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Site Status

511.147.01072 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

511.147.01007 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Site Status

511.147.01055 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

511.147.01048 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Site Status

511.147.01068 Boehringer Ingelheim Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

511.147.01063 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Site Status

511.147.01010 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Site Status

511.147.01036 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Site Status

511.147.01018 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Site Status

511.147.01032 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

511.147.01011 Boehringer Ingelheim Investigational Site

Katy, Texas, United States

Site Status

511.147.01012 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

511.147.01026 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

511.147.01005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

511.147.01069 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Site Status

511.147.01040 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Site Status

511.147.01049 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Site Status

511.147.01029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

511.147.01075 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

511.147.01054 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Site Status

511.147.01045 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

511.147.01038 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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511.147

Identifier Type: -

Identifier Source: org_study_id

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