Clinical trial NCT00612742: Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Cardiovascular event
Breast Cancer
Testosterone
Menopause
Hypoactive Sexual Desire Disorder
Lead sponsor: BioSante Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 3656
Sex: FEMALE
Minimum age (years): 50
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, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).


Eligibility criteria: Inclusion Criteria:

Postmenopausal female subjects

* at least 50 years of age
* with at least two points of cardiovascular risk
* with a clinical diagnosis of HSDD.

Exclusion Criteria:

Subjects must not

* require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
* have used androgen therapy within 2 months of randomization,
* have a history of estrogen-dependent neoplasia or any gynecologic cancer,
* have a history of cancer of any kind in the past 10 years prior to randomization,
* have a history of malignant melanoma or a history of invasive cancer at any time,
* have a screening mammogram with any finding that requires follow up within 6 months of randomization,
* have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
* have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Primary outcomes:
measure: The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
timeFrame: 2011 primary outcome analysis for NDA submission
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: BioSante Site #215
state: Alabama
city: Birmingham
country: United States
facility: BioSante Site 185
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: Huntsville
country: United States
facility: BioSante Site 196
state: Alabama
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: Glendale
country: United States
facility: BioSante Site 027
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: Tucson
country: United States
facility: BioSante Site 040
state: Arizona
city: Hot Springs
country: United States
facility: BioSante Site 052
state: Arkansas
city: Jonesboro
country: United States
facility: BioSante Site 100
state: Arkansas
city: Little Rock
country: United States
facility: BioSante Site #060
state: Arkansas
city: Little Rock
country: United States
facility: BioSante Site 155
state: Arkansas
city: Los Angeles
country: United States
facility: BioSante Site 011
state: California
city: Palm Springs
country: United States
facility: BioSante Site 094
state: California
city: Roseville
country: United States
facility: BioSante Site 043
state: California
city: Sacramento
country: United States
facility: BioSante Site 162
state: California
city: Sacramento
country: United States
facility: BioSante Site 025
state: California
city: San Diego
country: United States
facility: BioSante Site 112
state: California
city: San Diego
country: United States
facility: BioSante Site 008
state: California
city: San Diego
country: United States
facility: BioSante Site #070
state: California
city: San Diego
country: United States
facility: BioSante Site 205
state: California
city: San Diego
country: United States
facility: BioSante Site #192
state: California
city: Walnut Creek
country: United States
facility: BioSante Site 159
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: Lakewood
country: United States
facility: BioSante Site 026
state: Colorado
city: Farmington
country: United States
facility: BioSante Site 166
state: Connecticut
city: Hartford
country: United States
facility: BioSante Site 103
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: Ridgefield
country: United States
facility: BioSante Site 036
state: Connecticut
city: Washington
country: United States
facility: BioSante Site 013
state: District of Columbia
city: Aventura
country: United States
facility: BioSante Site 118
state: Florida
city: Crystal River
country: United States
facility: BioSante Site 139
state: Florida
city: Jacksonville
country: United States
facility: BioSante Site 143
state: Florida
city: Melbourne
country: United States
facility: BioSante Site 180
state: Florida
city: Miami
country: United States
facility: BioSante Site 024
state: Florida
city: Pinellas Park
country: United States
facility: BioSante Site #219
state: Florida
city: Saint Petersburg
country: United States
facility: BioSante Site 041
state: Florida
city: Tampa
country: United States
facility: BioSante Site 152
state: Florida
city: West Palm Beach
country: United States
facility: BioSante Site 009
state: Florida
city: Atlanta
country: United States
facility: BioSante Site 115
state: Georgia
city: Meridian
country: United States
facility: BioSante Site 017
state: Idaho
city: Addison
country: United States
facility: BioSante Site 189
state: Illinois
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: South Bend
country: United States
facility: BioSante Site 022
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: Shreveport
country: United States
facility: BioSante Site 005
state: Louisiana
city: Baltimore
country: United States
facility: BioSante Site 004
state: Maryland
city: Greenbelt
country: United States
facility: BioSante Site 195
state: Maryland
city: Rockville
country: United States
facility: BioSante Site 066
state: Maryland
city: Fall River
country: United States
facility: BioSante Site #206
state: Massachusetts
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: Detroit
country: United States
facility: BioSante Site 044
state: Michigan
city: Grand Rapids
country: United States
facility: BioSante Site 047
state: Michigan
city: Paw Paw
country: United States
facility: BioSante Site 105
state: Michigan
city: Saginaw
country: United States
facility: BioSante Site 033
state: Michigan
city: Saint Clair Shores
country: United States
facility: BioSante Site 031
state: Michigan
city: Edina
country: United States
facility: BioSante Site #208
state: Minnesota
city: Saint Paul
country: United States
facility: BioSante Site 198
state: Minnesota
city: Olive Branch
country: United States
facility: BioSante Site 081
state: Mississippi
city: Saint Louis
country: United States
facility: BioSante Site 104
state: Missouri
city: Billings
country: United States
facility: BioSante Site 127
state: Montana
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 018
state: Nevada
city: Las Vegas
country: United States
facility: BioSante Site #217
state: Nevada
city: Lawrenceville
country: United States
facility: BioSante Site 125
state: New Jersey
city: Albuquerque
country: United States
facility: BioSante Site 179
state: New Mexico
city: New York
country: United States
facility: BioSante Site 019
state: New York
city: Poughkeepsie
country: United States
facility: BioSante Site 015
state: New York
city: Purchase
country: United States
facility: BioSante Site 161
state: New York
city: Charlotte
country: United States
facility: BioSante Site 079
state: North Carolina
city: Hickory
country: United States
facility: BioSante Site 072
state: North Carolina
city: Raleigh
country: United States
facility: BioSante Site 107
state: North Carolina
city: Winston-Salem
country: United States
facility: BioSante Site 034
state: North Carolina
city: Winston-Salem
country: United States
facility: BioSante Site 058
state: North Carolina
city: Winston-Salem
country: United States
facility: BioSante Site 061
state: North Carolina
city: Winston-Salem
country: United States
facility: BioSante Site 131
state: North Carolina
city: Fargo
country: United States
facility: BioSante Site 056
state: North Dakota
city: Minot
country: United States
facility: BioSante Site 071
state: North Dakota
city: Akron
country: United States
facility: BioSante Site #210
state: Ohio
city: Beachwood
country: United States
facility: BioSante Site #130
state: Ohio
city: Cincinnati
country: United States
facility: BioSante Site #212
state: Ohio
city: Cleveland
country: United States
facility: BioSante Site 101
state: Ohio
city: Columbus
country: United States
facility: BioSante Site #213
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: 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 #050
state: Oregon
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: West Reading
country: United States
facility: BioSante Site 074
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: 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: Bristol
country: United States
facility: BioSante Site 093
state: Tennessee
city: Chattanooga
country: United States
facility: BioSante Site 069
state: Tennessee
city: Germantown
country: United States
facility: BioSante Site 002
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: BioSante Site #220
state: Texas
city: Dallas
country: United States
facility: BioSante Site 147
state: Texas
city: Houston
country: United States
facility: BioSante Site 039
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 #211
state: Texas
city: San Antonio
country: United States
facility: BioSante Site 084
state: Texas
city: Murray
country: United States
facility: BioSante Site #218
state: Utah
city: Salt Lake City
country: United States
facility: BioSante Site 102
state: Utah
city: Sandy
country: United States
facility: BioSante Site 168
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: Seattle
country: United States
facility: BioSante Site 128
state: Washington
city: Milwaukee
country: United States
facility: BioSante Site #158
state: Wisconsin
city: Vancouver
country: Canada
facility: BioSante Site #175
state: British Columbia
city: Winnipeg
country: Canada
facility: BioSante Site #164
state: Manitoba
city: Hamilton
country: Canada
facility: BioSante Site 190
state: Ontario
city: Newmarket
country: Canada
facility: BioSante Site #088
state: Ontario
city: NewMarket
country: Canada
facility: BioSante Site 088
state: Ontario
city: Sarnia
country: Canada
facility: BioSante Site 188
state: Ontario
city: Windsor
country: Canada
facility: BioSante Site 054
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:
citation: White WB, Grady D, Giudice LC, Berry SM, Zborowski J, Snabes MC. A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder. Am Heart J. 2012 Jan;163(1):27-32. doi: 10.1016/j.ahj.2011.09.021. Epub 2011 Nov 21.