Clinical trial NCT00657501: Safety and Efficacy of LibiGel® for 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: testosterone
hypoactive sexual desire disorder
menopause
Lead sponsor: BioSante Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 575
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 transdermal 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: Time Frame: Baseline and 21-24 weeks.
Secondary outcomes:
measure: Change from baseline over time for multiple efficacy measurements
timeFrame: change over timepoints from baseline period
Other outcomes:
Locations:
city: Mobile
country: United States
facility: BioSante Site #146
state: Alabama
city: Chandler
country: United States
facility: BioSante Site #171
state: Arizona
city: Glendale
country: United States
facility: BioSante Site #145
state: Arizona
city: Phoenix
country: United States
facility: BioSante Site #121
state: Arizona
city: Tucson
country: United States
facility: BioSante Site #137
state: Arizona
city: Jonesboro
country: United States
facility: BioSante Site #100
state: Arkansas
city: Little Rock
country: United States
facility: BioSante Site #155
state: Arkansas
city: Berkely
country: United States
facility: BioSante Site #221
state: California
city: Sacramento
country: United States
facility: BioSante Site #162
state: California
city: San Diego
country: United States
facility: BioSante Site #112
state: California
city: Walnut Creek
country: United States
facility: BioSante Site #159
state: California
city: Lakewood
country: United States
facility: BioSante Site #026
state: Colorado
city: Farmington
country: United States
facility: BioSante Site #166
state: Connecticut
city: New Britain
country: United States
facility: BioSante Site #132
state: Connecticut
city: New London
country: United States
facility: BioSante Site #151
state: Connecticut
city: Jacksonville
country: United States
facility: BioSante Site #143
state: Florida
city: Orlando
country: United States
facility: BioSante Site #111
state: Florida
city: Tampa
country: United States
facility: BioSante Site #152
state: Florida
city: Atlanta
country: United States
facility: BioSante Site #115
state: Georgia
city: Roswell
country: United States
facility: BioSante Site #141
state: Georgia
city: Idaho Falls
country: United States
facility: BioSante Site #202
state: Idaho
city: Meridian
country: United States
facility: BioSante Site #017
state: Idaho
city: Champaign
country: United States
facility: BioSante Site #156
state: Illinois
city: Chicago
country: United States
facility: BioSante Site #045
state: Illinois
city: Chicago
country: United States
facility: BioSante Site #149
state: Illinois
city: Chicago
country: United States
facility: BioSante Site #133
state: Illinois
city: Newburgh
country: United States
facility: BioSante Site #167
state: Indiana
city: Overland Park
country: United States
facility: BioSante Site #163
state: Kansas
city: Lexington
country: United States
facility: BioSante Site #214
state: Kentucky
city: Lexington
country: United States
facility: BioSante Site #136
state: Kentucky
city: Mandeville
country: United States
facility: BioSante Site #157
state: Louisiana
city: Metarie
country: United States
facility: BioSante Site #110
state: Louisiana
city: Ann Arbor
country: United States
facility: BioSante Site #035
state: Michigan
city: Bingham Farms
country: United States
facility: BioSante Site #124
state: Michigan
city: Kalamazoo
country: United States
facility: BioSante Site #105
state: Michigan
city: St. Louis
country: United States
facility: BioSante Site #104
state: Missouri
city: Billings
country: United States
facility: BioSante Site #127
state: Montana
city: Las Vegas
country: United States
facility: BioSante Site #114
state: Nevada
city: Purchase
country: United States
facility: BioSante Site #161
state: New York
city: Raleigh
country: United States
facility: BioSante Site #107
state: North Carolina
city: Winston Salem
country: United States
facility: BioSante Site #131
state: North Carolina
city: Beachwood
country: United States
facility: BioSante Site #130
state: Ohio
city: Cleveland
country: United States
facility: BioSante Site #101
state: Ohio
city: Englewood
country: United States
facility: BioSante Site #160
state: Ohio
city: Gallipolis
country: United States
facility: BioSante Site #153
state: Ohio
city: Kettering
country: United States
facility: Site #170
state: Ohio
city: Mayfield Heights
country: United States
facility: BioSante Site #116
state: Ohio
city: West Chester
country: United States
facility: BioSante Site #138
state: Ohio
city: Tulsa
country: United States
facility: BioSante Site #129
state: Oklahoma
city: Eugene
country: United States
facility: BioSante Site #106
state: Oregon
city: Medford
country: United States
facility: BioSante Site #126
state: Oregon
city: Portland
country: United States
facility: BioSante Site #203
state: Oregon
city: Jenkintown
country: United States
facility: BioSante Site #165
state: Pennsylvania
city: Pittsburgh
country: United States
facility: BioSante Site #142
state: Pennsylvania
city: Sellersville
country: United States
facility: BioSante Site #099
state: Pennsylvania
city: Warwick
country: United States
facility: BioSante Site #075
state: Rhode Island
city: Anderson
country: United States
facility: BioSante Site #117
state: South Carolina
city: North Jackson
country: United States
facility: BioSante Site #120
state: Tennessee
city: Dallas
country: United States
facility: BioSante Site #147
state: Texas
city: Houston
country: United States
facility: BioSante Site #122
state: Texas
city: Hurst
country: United States
facility: BioSante Site #154
state: Texas
city: San Antonio
country: United States
facility: BioSante Site #084
state: Texas
city: Pleasant Grove
country: United States
facility: BioSante Site #144
state: Utah
city: Salt Lake City
country: United States
facility: BioSante Site #102
state: Utah
city: Seattle
country: United States
facility: BioSante Site #128
state: Washington
city: Walla Walla
country: United States
facility: BioSante Site #183
state: Washington
city: Vancouver
country: Canada
facility: BioSante Site #175
state: British Columbia
city: Ottawa
country: Canada
facility: BioSante Site #123
state: Ontario
city: Quebec City
country: Canada
facility: BioSante Site #109
state: Quebec
Study officials:
affiliation: BioSante Pharmaceuticals, Inc.
name: Michael C Snabes, MD, PhD
role: STUDY_DIRECTOR
References: