Clinical trial NCT01057901: Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
Official title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 748
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in the Number of Satisfying Sexual Events
timeFrame: baseline to 24 weeks
measure: Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
timeFrame: baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 511.156.01059 Boehringer Ingelheim Investigational Site
state: Alabama
city: Tucson
country: United States
facility: 511.156.01084 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: 511.156.01053 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: 511.156.01069 Boehringer Ingelheim Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: 511.156.01063 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: 511.156.01076 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: 511.156.01039 Boehringer Ingelheim Investigational Site
state: California
city: Berkeley
country: United States
facility: 511.156.01070 Boehringer Ingelheim Investigational Site
state: California
city: La Mesa
country: United States
facility: 511.156.01075 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 511.156.01087 Boehringer Ingelheim Investigational Site
state: California
city: Newport Beach
country: United States
facility: 511.156.01064 Boehringer Ingelheim Investigational Site
state: California
city: Oceanside
country: United States
facility: 511.156.01016 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.156.01007 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.156.01038 Boehringer Ingelheim Investigational Site
state: California
city: Colorado Springs
country: United States
facility: 511.156.01067 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 511.156.01036 Boehringer Ingelheim Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: 511.156.01092 Boehringer Ingelheim Investigational Site
state: Colorado
city: New London
country: United States
facility: 511.156.01027 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Coral Gables
country: United States
facility: 511.156.01022 Boehringer Ingelheim Investigational Site
state: Florida
city: Deland
country: United States
facility: 511.156.01042 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 511.156.01047 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 511.156.01051 Boehringer Ingelheim Investigational Site
state: Florida
city: Gainseville
country: United States
facility: 511.156.01011 Boehringer Ingelheim Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: 511.156.01078 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 511.156.01095 Boehringer Ingelheim Investigational Site
state: Florida
city: Plantation
country: United States
facility: 511.156.01046 Boehringer Ingelheim Investigational Site
state: Florida
city: Columbus
country: United States
facility: 511.156.01056 Boehringer Ingelheim Investigational Site
state: Georgia
city: Marietta
country: United States
facility: 511.156.01045 Boehringer Ingelheim Investigational Site
state: Georgia
city: Roswell
country: United States
facility: 511.156.01021 Boehringer Ingelheim Investigational Site
state: Georgia
city: Savannah
country: United States
facility: 511.156.01081 Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: 511.156.01066 Boehringer Ingelheim Investigational Site
state: Idaho
city: Chicago
country: United States
facility: 511.156.01025 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 511.156.01028 Boehringer Ingelheim Investigational Site
state: Illinois
city: South Bend
country: United States
facility: 511.156.01089 Boehringer Ingelheim Investigational Site
state: Indiana
city: Wichita
country: United States
facility: 511.156.01010 Boehringer Ingelheim Investigational Site
state: Kansas
city: Lexington
country: United States
facility: 511.156.01008 Boehringer Ingelheim Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: 511.156.01034 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: 511.156.01012 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Boston
country: United States
facility: 511.156.01074 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 511.156.01079 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Haverhill
country: United States
facility: 511.156.01080 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: 511.156.01006 Boehringer Ingelheim Investigational Site
state: Michigan
city: Paw Paw
country: United States
facility: 511.156.01086 Boehringer Ingelheim Investigational Site
state: Michigan
city: Chaska
country: United States
facility: 511.156.01005 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Olive Branch
country: United States
facility: 511.156.01013 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Las Vegas
country: United States
facility: 511.156.01088 Boehringer Ingelheim Investigational Site
state: Nevada
city: New Brunswick
country: United States
facility: 511.156.01001 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Plainsboro
country: United States
facility: 511.156.01055 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: 511.156.01009 Boehringer Ingelheim Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: 511.156.01037 Boehringer Ingelheim Investigational Site
state: New York
city: Purchase
country: United States
facility: 511.156.01031 Boehringer Ingelheim Investigational Site
state: New York
city: Cary
country: United States
facility: 511.156.01024 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 511.156.01065 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: 511.156.01029 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 511.156.01002 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: 511.156.01040 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 511.156.01026 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: 511.156.01093 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: 511.156.01052 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Beachwood
country: United States
facility: 511.156.01017 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 511.156.01032 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 511.156.01033 Boehringer Ingelheim Investigational Site
state: Ohio
city: Englewood
country: United States
facility: 511.156.01068 Boehringer Ingelheim Investigational Site
state: Ohio
city: Ashland
country: United States
facility: 511.156.01077 Boehringer Ingelheim Investigational Site
state: Oregon
city: Medford
country: United States
facility: 511.156.01072 Boehringer Ingelheim Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: 511.156.01082 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: 511.156.01094 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: 511.156.01083 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: 511.156.01048 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 511.156.01058 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Watertown
country: United States
facility: 511.156.01085 Boehringer Ingelheim Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: 511.156.01073 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: 511.156.01041 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: 511.156.01035 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: 511.156.01091 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 511.156.01060 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 511.156.01003 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 511.156.01054 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 511.156.01050 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.156.01014 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.156.01049 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 511.156.01015 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.156.01090 Boehringer Ingelheim Investigational Site
state: Virginia
city: Seattle
country: United States
facility: 511.156.01020 Boehringer Ingelheim Investigational Site
state: Washington
city: Calgary
country: Canada
facility: 511.156.02004 Boehringer Ingelheim Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: 511.156.02010 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 511.156.02009 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 511.156.02014 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 511.156.02012 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: 511.156.02017 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Woodstock
country: Canada
facility: 511.156.02007 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: 511.156.02008 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: 511.156.02001 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: 511.156.02013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: 511.156.02006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 511.156.02005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 511.156.02016 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: 511.156.02015 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 511.156.02003 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: 511.156.02002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.