Clinical trial NCT00613002: Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: hypoactive sexual desire disorder
testosterone
menopause
Lead sponsor: BioSante Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 597
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women


Eligibility criteria: Inclusion Criteria:

* Must be between the ages of 30 to 65 years
* Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion Criteria:

* A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
* Any systemic skin diseases or local skin abnormalities in the area of application
* Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
* A medical condition that could affect or interfere with sexual function
* Using a systemic topical gel or cream estrogen therapy.

Primary outcomes:
measure: Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.
timeFrame: Baseline and 21-24 weeks.
Secondary outcomes:
measure: Change from baseline over time for multiple efficacy measurements
timeFrame: change over timepoints from baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: BioSante Site #215
state: Alabama
city: Hoover
country: United States
facility: BioSante Site #095
state: Alabama
city: Huntsville
country: United States
facility: BioSante Site #014
state: Alabama
city: Glendale
country: United States
facility: BioSante Site #027
state: Arizona
city: Tucson
country: United States
facility: BioSante Site #040
state: Arizona
city: Hot Springs
country: United States
facility: BioSante Site #052
state: Arkansas
city: Buena Park
country: United States
facility: BioSante Site #182
state: California
city: San Diego
country: United States
facility: BioSante Site #008
state: California
city: Denver
country: United States
facility: BioSante Site #007
state: Colorado
city: Denver
country: United States
facility: BioSante Site #216
state: Colorado
city: Ridgefield
country: United States
facility: BioSante Site #036
state: Connecticut
city: Washington
country: United States
facility: BioSante Site #013
state: District of Columbia
city: Miami
country: United States
facility: BioSante Site #024
state: Florida
city: Pinellas Park
country: United States
facility: BioSante Site #219
state: Florida
city: St. Petersburg
country: United States
facility: BioSante Site #041
state: Florida
city: West Palm Beach
country: United States
facility: BioSante Site #009
state: Florida
city: Addison
country: United States
facility: BioSante Site #189
state: Illinois
city: Shreveport
country: United States
facility: BioSante Site #005
state: Louisiana
city: Baltimore
country: United States
facility: BioSante Site #004
state: Maryland
city: Detroit
country: United States
facility: BioSante Site #044
state: Michigan
city: Grand Rapids
country: United States
facility: BioSante Site #047
state: Michigan
city: Saginaw
country: United States
facility: BioSante Site #033
state: Michigan
city: St. Clair Shores
country: United States
facility: BioSante Site #031
state: Michigan
city: Edina
country: United States
facility: BioSante Site #208
state: Minnesota
city: St. Paul
country: United States
facility: BioSante Site #198
state: Minnesota
city: Missoula
country: United States
facility: BioSante Site #051
state: Montana
city: Lincoln
country: United States
facility: BioSante Site #006
state: Nebraska
city: Las Vegas
country: United States
facility: BioSante Site #217
state: Nevada
city: Poughkeepsie
country: United States
facility: BioSante Site #015
state: New York
city: Cary
country: United States
facility: BioSante Site #059
state: North Carolina
city: Charlotte
country: United States
facility: BioSante Site #079
state: North Carolina
city: Winston-Salem
country: United States
facility: BioSante Site #061
state: North Carolina
city: Fargo
country: United States
facility: BioSante Site #056
state: North Dakota
city: Akron
country: United States
facility: BioSante Site #210
state: Ohio
city: Cincinnati
country: United States
facility: BioSante Site #212
state: Ohio
city: Columbus
country: United States
facility: BioSante Site #213
state: Ohio
city: Eugene
country: United States
facility: BioSante Site #050
state: Oregon
city: Wexford
country: United States
facility: BioSante Site #197
state: Pennsylvania
city: Columbia
country: United States
facility: BioSante Site #089
state: South Carolina
city: Greer
country: United States
facility: BioSante Site #209
state: South Carolina
city: Hilton Head Island
country: United States
facility: BioSante Site #097
state: South Carolina
city: Mount Pleasant
country: United States
facility: BioSante Site #038
state: South Carolina
city: Watertown
country: United States
facility: BioSante Site #049
state: South Dakota
city: Bristol
country: United States
facility: BioSante Site #093
state: Tennessee
city: Chattanooga
country: United States
facility: BioSante Site #069
state: Tennessee
city: Memphis
country: United States
facility: BioSante Site #078
state: Tennessee
city: Nashville
country: United States
facility: BioSante Site #042
state: Tennessee
city: Austin
country: United States
facility: BioSante Site #048
state: Texas
city: Corpus Christi
country: United States
facility: BioSante Site #073
state: Texas
city: Dallas
country: United States
facility: BioSane Site #220
state: Texas
city: Houston
country: United States
facility: BioSante Site #039
state: Texas
city: San Antonio
country: United States
facility: BioSante Site #211
state: Texas
city: Murray
country: United States
facility: BioSante Site #218
state: Utah
city: Williston
country: United States
facility: BioSante Site #096
state: Vermont
city: Charlottesville
country: United States
facility: BioSante Site #003
state: Virginia
city: Norfolk
country: United States
facility: BioSante Site #086
state: Virginia
city: Richmond
country: United States
facility: BioSante Site #053
state: Virginia
city: Virginia Beach
country: United States
facility: BioSante Site #090
state: Virginia
city: Mountlake Terrace
country: United States
facility: BioSante Site #083
state: Washington
city: Tacoma
country: United States
facility: BioSante Site #181
state: Washington
city: Sarnia
country: Canada
facility: BioSante Site #188
state: Ontario
city: Windsor
country: Canada
facility: BioSante Site #054
state: Ontario
city: Shawinigan
country: Canada
facility: BioSante Site #193
state: Quebec
Study officials:
affiliation: BioSante Pharmaceuticals, Inc.
name: Michael C Snabes, MD, PhD
role: STUDY_DIRECTOR
References: