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

Sexual Dysfunctions, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01057901
• Other study ID #: 511.156
• Status: Terminated
• Phase: Phase 3
• First received: January 25, 2010
• Last updated: June 16, 2014
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2014
• Source: Sprout Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 748
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Flibanserin
Flibanserin 100mg administered at bedtime for 24 weeks
• Placebo
This is the matched placebo which will be administered two tablets daily at bedtime.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sprout Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Satisfying Sexual Events	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	No
Primary	Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain	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	No