Clinical trial NCT01235754: Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Official title: A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) 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: 2010-11-07
Enrollment: 626
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.


Eligibility criteria: Inclusion Criteria:

* must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

Exclusion Criteria:

* Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator

Primary outcomes:
measure: Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study
timeFrame: 12 weeks
Secondary outcomes:
measure: change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study
timeFrame: 12 weeks
measure: change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hoover
country: United States
facility: BioSante Site #095
state: Alabama
city: Huntsville
country: United States
facility: BioSante Site #014
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: Hot Springs
country: United States
facility: BioSante Site #052
state: Arkansas
city: Little Rock
country: United States
facility: BioSante Site #155
state: Arkansas
city: Berkeley
country: United States
facility: BioSante Site #221
state: California
city: Buena Park
country: United States
facility: BioSante Site #182
state: California
city: Sacramento
country: United States
facility: BioSante Site #162
state: California
city: San Diego
country: United States
facility: BioSante Site #008
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: Lakewood
country: United States
facility: BioSante Site #026
state: Colorado
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: Jacksonville
country: United States
facility: BioSante Site #143
state: Florida
city: Miami
country: United States
facility: BioSante Site #024
state: Florida
city: Orlando
country: United States
facility: BioSante Site #111
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: 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: Addison
country: United States
facility: BioSante Site #189
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: Metarie
country: United States
facility: BioSante Site #110
state: Louisiana
city: Shreveport
country: United States
facility: BioSante Site #005
state: Louisiana
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: Kalamazoo
country: United States
facility: BioSante Site #105
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: St. 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: Poughkeepsie
country: United States
facility: BioSante Site #015
state: New York
city: Cary
country: United States
facility: BioSante Site #059
state: North Carolina
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: Fargo
country: United States
facility: BioSante Site #056
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: 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: Jenkintown
country: United States
facility: BioSante Site #165
state: Pennsylvania
city: Sellersville
country: United States
facility: BioSante Site #099
state: Pennsylvania
city: Wexford
country: United States
facility: BioSante Site #197
state: Pennsylvania
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: Watertown
country: United States
facility: BioSante Site #049
state: South Dakota
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: North Jackson
country: United States
facility: BioSante Site #120
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: Murray
country: United States
facility: BioSante Site #218
state: Utah
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: 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: Mountlake Terrace
country: United States
facility: BioSante Site #083
state: Washington
city: Seattle
country: United States
facility: BioSante Site #128
state: Washington
city: Tacoma
country: United States
facility: BioSante Site #181
state: Washington
city: Walla Walla
country: United States
facility: BioSante Site #183
state: Washington
city: Ottawa
country: Canada
facility: BioSante Site# 123
state: Ontario
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
name: Michael C Snabes, MD, PhD
role: STUDY_DIRECTOR
References: