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Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

NCT ID: NCT01057901

Last Updated: 2014-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

748 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal 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 100 mg administered at bedtime

Group Type EXPERIMENTAL

Flibanserin

Intervention Type DRUG

Flibanserin 100mg administered at bedtime for 24 weeks

Placebo

This is the matched placebo which will be administered two tablets daily at bedtime.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

This is the matched placebo which will be administered two tablets daily at bedtime.

Interventions

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Flibanserin

Flibanserin 100mg administered at bedtime for 24 weeks

Intervention Type DRUG

Placebo

This is the matched placebo which will be administered two tablets daily at bedtime.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Naturally postmenopausal women of any age with at least one ovary
* Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
* Stable, monogamous heterosexual relationship for at least one year
* Willing to discuss sexual issues
* Willing to engage in sexual activity at least once a month
* Normal Pap smear
* Normal mammogram
* Normal uterine lining
* Able to comply with daily use of handheld data entry device

Exclusion Criteria

* Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
* Partner with inadequately treated organic or psychosexual dysfunction
* Sexual function impaired by psychiatric disorder
* Sexual function impaired by gynecological disorder
* Major Depression
* Suicidal behavior or ideation
* Major life stress that could impair sexual function
* Substance abuse
Minimum Eligible Age

35 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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511.156.01059 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

511.156.01084 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Site Status

511.156.01053 Boehringer Ingelheim Investigational Site

Tuscon, Arizona, United States

Site Status

511.156.01069 Boehringer Ingelheim Investigational Site

Tuscon, Arizona, United States

Site Status

511.156.01063 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

511.156.01076 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

511.156.01039 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Site Status

511.156.01070 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

511.156.01075 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Site Status

511.156.01087 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

511.156.01064 Boehringer Ingelheim Investigational Site

Newport Beach, California, United States

Site Status

511.156.01016 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Site Status

511.156.01007 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

511.156.01038 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

511.156.01067 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Site Status

511.156.01036 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

511.156.01092 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

511.156.01027 Boehringer Ingelheim Investigational Site

New London, Connecticut, United States

Site Status

511.156.01022 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Site Status

511.156.01042 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

511.156.01047 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

511.156.01051 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

511.156.01011 Boehringer Ingelheim Investigational Site

Gainseville, Florida, United States

Site Status

511.156.01078 Boehringer Ingelheim Investigational Site

Lake Worth, Florida, United States

Site Status

511.156.01095 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

511.156.01046 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Site Status

511.156.01056 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Site Status

511.156.01045 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Site Status

511.156.01021 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Site Status

511.156.01081 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Site Status

511.156.01066 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

Site Status

511.156.01025 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

511.156.01028 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

511.156.01089 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Site Status

511.156.01010 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Site Status

511.156.01008 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

511.156.01034 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Site Status

511.156.01012 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Site Status

511.156.01074 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

511.156.01079 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

511.156.01080 Boehringer Ingelheim Investigational Site

Haverhill, Massachusetts, United States

Site Status

511.156.01006 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

511.156.01086 Boehringer Ingelheim Investigational Site

Paw Paw, Michigan, United States

Site Status

511.156.01005 Boehringer Ingelheim Investigational Site

Chaska, Minnesota, United States

Site Status

511.156.01013 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Site Status

511.156.01088 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

511.156.01001 Boehringer Ingelheim Investigational Site

New Brunswick, New Jersey, United States

Site Status

511.156.01055 Boehringer Ingelheim Investigational Site

Plainsboro, New Jersey, United States

Site Status

511.156.01037 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Site Status

511.156.01031 Boehringer Ingelheim Investigational Site

Purchase, New York, United States

Site Status

511.156.01009 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Site Status

511.156.01024 Boehringer Ingelheim Investigational Site

Cary, North Carolina, United States

Site Status

511.156.01065 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

511.156.01029 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Site Status

511.156.01002 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Site Status

511.156.01040 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Site Status

511.156.01026 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

511.156.01093 Boehringer Ingelheim Investigational Site

Bismarck, North Dakota, United States

Site Status

511.156.01052 Boehringer Ingelheim Investigational Site

Fargo, North Dakota, United States

Site Status

511.156.01017 Boehringer Ingelheim Investigational Site

Beachwood, Ohio, United States

Site Status

511.156.01032 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

511.156.01033 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

511.156.01068 Boehringer Ingelheim Investigational Site

Englewood, Ohio, United States

Site Status

511.156.01077 Boehringer Ingelheim Investigational Site

Ashland, Oregon, United States

Site Status

511.156.01072 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

511.156.01082 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

511.156.01094 Boehringer Ingelheim Investigational Site

West Reading, Pennsylvania, United States

Site Status

511.156.01083 Boehringer Ingelheim Investigational Site

Warwick, Rhode Island, United States

Site Status

511.156.01048 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Site Status

511.156.01058 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

511.156.01085 Boehringer Ingelheim Investigational Site

Watertown, South Dakota, United States

Site Status

511.156.01073 Boehringer Ingelheim Investigational Site

Bristol, Tennessee, United States

Site Status

511.156.01041 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Site Status

511.156.01035 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Site Status

511.156.01091 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

Site Status

511.156.01060 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Site Status

511.156.01003 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

511.156.01054 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

511.156.01050 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Site Status

511.156.01014 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

511.156.01049 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

511.156.01015 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

511.156.01090 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

511.156.01020 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Site Status

511.156.02004 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

511.156.02010 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Site Status

511.156.02009 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

511.156.02014 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

511.156.02012 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

511.156.02017 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

511.156.02007 Boehringer Ingelheim Investigational Site

Woodstock, New Brunswick, Canada

Site Status

511.156.02008 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

511.156.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

511.156.02013 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Site Status

511.156.02006 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

Site Status

511.156.02005 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

511.156.02016 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

511.156.02002 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

511.156.02015 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

511.156.02003 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med. 2017 Jun;14(6):834-842. doi: 10.1016/j.jsxm.2017.03.258.

Reference Type DERIVED
PMID: 28583342 (View on PubMed)

Other Identifiers

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511.156

Identifier Type: -

Identifier Source: org_study_id

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