Clinical trial NCT00996164: Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Official title: A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the 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: 1090
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.


Eligibility criteria: Inclusion criteria:

1. Premenopausal women who are 18 years old and older
2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
3. Stable, monogamous heterosexual relationship for at least one year.
4. Willing to discuss sexual issues.
5. Willing to engage in sexual activity at least once a month
6. Normal pap smear
7. Must use medically acceptable method of contraception
8. Able to comply with daily use of a handheld entry device

Exclusion criteria:

1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
3. Partner with inadequately treated organic or psychosexual dysfunction
4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
5. Sexual function impaired by psychiatric disorder
6. Sexual function impaired by gynecological disorder
7. Major life stress that could impair sexual function
8. Substance abuse

Primary outcomes:
measure: The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
timeFrame: 24 weeks
measure: Change From Baseline in the SSE Count From Baseline to 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 511.147.01074 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 511.147.01046 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 511.147.01042 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 511.147.01025 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 511.147.01073 Boehringer Ingelheim Investigational Site
state: Arizona
city: Encinitas
country: United States
facility: 511.147.01030 Boehringer Ingelheim Investigational Site
state: California
city: Fair Oaks
country: United States
facility: 511.147.01028 Boehringer Ingelheim Investigational Site
state: California
city: Irvine
country: United States
facility: 511.147.01037 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 511.147.01022 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.147.01035 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.147.01052 Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: 511.147.01016 Boehringer Ingelheim Investigational Site
state: California
city: Vista
country: United States
facility: 511.147.01021 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 511.147.01051 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 511.147.01071 Boehringer Ingelheim Investigational Site
state: Colorado
city: Farmington
country: United States
facility: 511.147.01053 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Groton
country: United States
facility: 511.147.01015 Boehringer Ingelheim Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: 511.147.01041 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 511.147.01064 Boehringer Ingelheim Investigational Site
state: Delaware
city: Washington
country: United States
facility: 511.147.01062 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Boynton Beach
country: United States
facility: 511.147.01003 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 511.147.01056 Boehringer Ingelheim Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: 511.147.01065 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.147.01020 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.147.01024 Boehringer Ingelheim Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: 511.147.01070 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 511.147.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 511.147.01019 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.147.01061 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.147.01066 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.147.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.147.01002 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 511.147.01009 Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: 511.147.01023 Boehringer Ingelheim Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: 511.147.01008 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 511.147.01044 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 511.147.01034 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: 511.147.01067 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: 511.147.01013 Boehringer Ingelheim Investigational Site
state: Maryland
city: Bingham Farms
country: United States
facility: 511.147.01031 Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: 511.147.01006 Boehringer Ingelheim Investigational Site
state: Missouri
city: Billings
country: United States
facility: 511.147.01014 Boehringer Ingelheim Investigational Site
state: Montana
city: Omaha
country: United States
facility: 511.147.01060 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: 511.147.01057 Boehringer Ingelheim Investigational Site
state: Nevada
city: Moorestown
country: United States
facility: 511.147.01039 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Endwell
country: United States
facility: 511.147.01017 Boehringer Ingelheim Investigational Site
state: New York
city: New Bern
country: United States
facility: 511.147.01047 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 511.147.01027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 511.147.01033 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 511.147.01004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.147.01050 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.147.01059 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 511.147.01058 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 511.147.01072 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 511.147.01007 Boehringer Ingelheim Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: 511.147.01055 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: 511.147.01048 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: 511.147.01068 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: 511.147.01063 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.147.01010 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.147.01036 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: 511.147.01018 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.147.01032 Boehringer Ingelheim Investigational Site
state: Texas
city: Katy
country: United States
facility: 511.147.01011 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.147.01012 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.147.01026 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 511.147.01005 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 511.147.01069 Boehringer Ingelheim Investigational Site
state: Utah
city: Norfolk
country: United States
facility: 511.147.01040 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 511.147.01049 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.147.01029 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.147.01075 Boehringer Ingelheim Investigational Site
state: Virginia
city: Renton
country: United States
facility: 511.147.01054 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 511.147.01045 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 511.147.01038 Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: