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

This study has been terminated.
(Study terminated for administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01057901
First received: January 25, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunctions, Psychological
Drug: Flibanserin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America

Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Change From Baseline in the Number of Satisfying Sexual Events [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 748
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057901

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

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01057901     History of Changes
Other Study ID Numbers: 511.156
Study First Received: January 25, 2010
Results First Received: April 14, 2014
Last Updated: June 16, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders
Sexual and Gender Disorders
Flibanserin
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Antagonists
Serotonin 5-HT2 Receptor Antagonists
Serotonin Agents
Serotonin Antagonists

ClinicalTrials.gov processed this record on October 29, 2014