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

June 16, 2014 updated by: Sprout Pharmaceuticals, Inc

24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

748

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • 511.156.02002 Boehringer Ingelheim Investigational Site
    • Alberta
      • Calgary, Alberta, Canada
        • 511.156.02004 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • 511.156.02010 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 511.156.02009 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 511.156.02014 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 511.156.02012 Boehringer Ingelheim Investigational Site
      • Winnipeg, Manitoba, Canada
        • 511.156.02017 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Woodstock, New Brunswick, Canada
        • 511.156.02007 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
        • 511.156.02008 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 511.156.02001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Barrie, Ontario, Canada
        • 511.156.02013 Boehringer Ingelheim Investigational Site
      • Burlington, Ontario, Canada
        • 511.156.02006 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 511.156.02005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 511.156.02016 Boehringer Ingelheim Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada
        • 511.156.02015 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 511.156.02003 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 511.156.01059 Boehringer Ingelheim Investigational Site
    • Arizona
      • Tucson, Arizona, United States
        • 511.156.01084 Boehringer Ingelheim Investigational Site
      • Tuscon, Arizona, United States
        • 511.156.01053 Boehringer Ingelheim Investigational Site
      • Tuscon, Arizona, United States
        • 511.156.01069 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • 511.156.01063 Boehringer Ingelheim Investigational Site
      • Little Rock, Arkansas, United States
        • 511.156.01076 Boehringer Ingelheim Investigational Site
    • California
      • Anaheim, California, United States
        • 511.156.01039 Boehringer Ingelheim Investigational Site
      • Berkeley, California, United States
        • 511.156.01070 Boehringer Ingelheim Investigational Site
      • La Mesa, California, United States
        • 511.156.01075 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 511.156.01087 Boehringer Ingelheim Investigational Site
      • Newport Beach, California, United States
        • 511.156.01064 Boehringer Ingelheim Investigational Site
      • Oceanside, California, United States
        • 511.156.01016 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.156.01007 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 511.156.01038 Boehringer Ingelheim Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • 511.156.01067 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 511.156.01036 Boehringer Ingelheim Investigational Site
      • Fort Collins, Colorado, United States
        • 511.156.01092 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New London, Connecticut, United States
        • 511.156.01027 Boehringer Ingelheim Investigational Site
    • Florida
      • Coral Gables, Florida, United States
        • 511.156.01022 Boehringer Ingelheim Investigational Site
      • Deland, Florida, United States
        • 511.156.01042 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, United States
        • 511.156.01047 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, United States
        • 511.156.01051 Boehringer Ingelheim Investigational Site
      • Gainseville, Florida, United States
        • 511.156.01011 Boehringer Ingelheim Investigational Site
      • Lake Worth, Florida, United States
        • 511.156.01078 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 511.156.01095 Boehringer Ingelheim Investigational Site
      • Plantation, Florida, United States
        • 511.156.01046 Boehringer Ingelheim Investigational Site
    • Georgia
      • Columbus, Georgia, United States
        • 511.156.01056 Boehringer Ingelheim Investigational Site
      • Marietta, Georgia, United States
        • 511.156.01045 Boehringer Ingelheim Investigational Site
      • Roswell, Georgia, United States
        • 511.156.01021 Boehringer Ingelheim Investigational Site
      • Savannah, Georgia, United States
        • 511.156.01081 Boehringer Ingelheim Investigational Site
    • Idaho
      • Boise, Idaho, United States
        • 511.156.01066 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 511.156.01025 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 511.156.01028 Boehringer Ingelheim Investigational Site
    • Indiana
      • South Bend, Indiana, United States
        • 511.156.01089 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 511.156.01010 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 511.156.01008 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • 511.156.01034 Boehringer Ingelheim Investigational Site
      • Shreveport, Louisiana, United States
        • 511.156.01012 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 511.156.01074 Boehringer Ingelheim Investigational Site
      • Boston, Massachusetts, United States
        • 511.156.01079 Boehringer Ingelheim Investigational Site
      • Haverhill, Massachusetts, United States
        • 511.156.01080 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • 511.156.01006 Boehringer Ingelheim Investigational Site
      • Paw Paw, Michigan, United States
        • 511.156.01086 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States
        • 511.156.01005 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States
        • 511.156.01013 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 511.156.01088 Boehringer Ingelheim Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States
        • 511.156.01001 Boehringer Ingelheim Investigational Site
      • Plainsboro, New Jersey, United States
        • 511.156.01055 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, United States
        • 511.156.01009 Boehringer Ingelheim Investigational Site
      • Poughkeepsie, New York, United States
        • 511.156.01037 Boehringer Ingelheim Investigational Site
      • Purchase, New York, United States
        • 511.156.01031 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Cary, North Carolina, United States
        • 511.156.01024 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, United States
        • 511.156.01065 Boehringer Ingelheim Investigational Site
      • Greensboro, North Carolina, United States
        • 511.156.01029 Boehringer Ingelheim Investigational Site
      • Raleigh, North Carolina, United States
        • 511.156.01002 Boehringer Ingelheim Investigational Site
      • Statesville, North Carolina, United States
        • 511.156.01040 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 511.156.01026 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • 511.156.01093 Boehringer Ingelheim Investigational Site
      • Fargo, North Dakota, United States
        • 511.156.01052 Boehringer Ingelheim Investigational Site
    • Ohio
      • Beachwood, Ohio, United States
        • 511.156.01017 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.156.01032 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 511.156.01033 Boehringer Ingelheim Investigational Site
      • Englewood, Ohio, United States
        • 511.156.01068 Boehringer Ingelheim Investigational Site
    • Oregon
      • Ashland, Oregon, United States
        • 511.156.01077 Boehringer Ingelheim Investigational Site
      • Medford, Oregon, United States
        • 511.156.01072 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 511.156.01082 Boehringer Ingelheim Investigational Site
      • West Reading, Pennsylvania, United States
        • 511.156.01094 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States
        • 511.156.01083 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States
        • 511.156.01048 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, United States
        • 511.156.01058 Boehringer Ingelheim Investigational Site
    • South Dakota
      • Watertown, South Dakota, United States
        • 511.156.01085 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States
        • 511.156.01073 Boehringer Ingelheim Investigational Site
      • Chattanooga, Tennessee, United States
        • 511.156.01041 Boehringer Ingelheim Investigational Site
      • Germantown, Tennessee, United States
        • 511.156.01035 Boehringer Ingelheim Investigational Site
      • Jackson, Tennessee, United States
        • 511.156.01091 Boehringer Ingelheim Investigational Site
      • Memphis, Tennessee, United States
        • 511.156.01060 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 511.156.01003 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 511.156.01054 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, United States
        • 511.156.01050 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 511.156.01014 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 511.156.01049 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 511.156.01015 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 511.156.01090 Boehringer Ingelheim Investigational Site
    • Washington
      • Seattle, Washington, United States
        • 511.156.01020 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Flibanserin 100 mg
Flibanserin 100 mg administered at bedtime
Drug: Flibanserin
Flibanserin 100mg administered at bedtime for 24 weeks
PLACEBO_COMPARATOR: Placebo
This is the matched placebo which will be administered two tablets daily at bedtime.
Drug: Placebo
This is the matched placebo which will be administered two tablets daily at bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Number of Satisfying Sexual Events
Time Frame: baseline to 24 weeks

The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:

Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).

"Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
baseline to 24 weeks
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
Time Frame: baseline to 24 weeks
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sprout Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (ESTIMATE)

January 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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