Clinical trial NCT00996372: Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Official title: 24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 949
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 through 24 weeks
measure: Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
timeFrame: baseline through 24 weeks
Secondary outcomes:
measure: Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)
timeFrame: change from baseline to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 511.130.01074 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 511.130.01046 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 511.130.01042 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 511.130.01025 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 511.130.01073 Boehringer Ingelheim Investigational Site
state: Arizona
city: Encinitas
country: United States
facility: 511.130.01030 Boehringer Ingelheim Investigational Site
state: California
city: Fair Oaks
country: United States
facility: 511.130.01028 Boehringer Ingelheim Investigational Site
state: California
city: Irvine
country: United States
facility: 511.130.01037 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 511.130.01022 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.130.01035 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.130.01052 Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: 511.130.01016 Boehringer Ingelheim Investigational Site
state: California
city: Vista
country: United States
facility: 511.130.01021 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 511.130.01051 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 511.130.01071 Boehringer Ingelheim Investigational Site
state: Colorado
city: Farmington
country: United States
facility: 511.130.01053 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Groton
country: United States
facility: 511.130.01015 Boehringer Ingelheim Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: 511.130.01041 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 511.130.01064 Boehringer Ingelheim Investigational Site
state: Delaware
city: Washington
country: United States
facility: 511.130.01062 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Boynton Beach
country: United States
facility: 511.130.01003 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 511.130.01056 Boehringer Ingelheim Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: 511.130.01065 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.130.01020 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.130.01024 Boehringer Ingelheim Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: 511.130.01070 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 511.130.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 511.130.01019 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.130.01061 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.130.01066 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.130.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.130.01002 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 511.130.01009 Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: 511.130.01023 Boehringer Ingelheim Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: 511.130.01008 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 511.130.01044 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 511.130.01034 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: 511.130.01067 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: 511.130.01013 Boehringer Ingelheim Investigational Site
state: Maryland
city: Bingham Farms
country: United States
facility: 511.130.01031 Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: 511.130.01006 Boehringer Ingelheim Investigational Site
state: Missouri
city: Billings
country: United States
facility: 511.130.01014 Boehringer Ingelheim Investigational Site
state: Montana
city: Omaha
country: United States
facility: 511.130.01060 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: 511.130.01057 Boehringer Ingelheim Investigational Site
state: Nevada
city: Moorestown
country: United States
facility: 511.130.01039 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Endwell
country: United States
facility: 511.130.01017 Boehringer Ingelheim Investigational Site
state: New York
city: New Bern
country: United States
facility: 511.130.01047 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 511.130.01027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 511.130.01033 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 511.130.01004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.130.01050 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.130.01059 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 511.130.01058 Boehringer Ingelheim Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: 511.130.01012 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 511.130.01072 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 511.130.01007 Boehringer Ingelheim Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: 511.130.01055 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: 511.130.01048 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: 511.130.01068 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: 511.130.01063 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.130.01010 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.130.01036 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: 511.130.01018 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.130.01032 Boehringer Ingelheim Investigational Site
state: Texas
city: Katy
country: United States
facility: 511.130.01011 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.130.01026 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 511.130.01005 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 511.130.01069 Boehringer Ingelheim Investigational Site
state: Utah
city: Norfolk
country: United States
facility: 511.130.01040 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 511.130.01049 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.130.01029 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.130.01075 Boehringer Ingelheim Investigational Site
state: Virginia
city: Renton
country: United States
facility: 511.130.01054 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 511.130.01045 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 511.130.01038 Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Simon JA, Kingsberg SA, Shumel B, Hanes V, Garcia M Jr, Sand M. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-40. doi: 10.1097/GME.0000000000000134.