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Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
transdermal testosterone gel 1%
placebo gel
Sponsored by
BioSante Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring testosterone, hypoactive sexual desire disorder, menopause

Eligibility Criteria

30 Years - 66 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • BioSante Site #095
  • BioSante Site #014
  • BioSante Site #146
  • BioSante Site #171
  • BioSante Site #145
  • BioSante Site #027
  • BioSante Site #121
  • BioSante Site #137
  • BioSante Site #052
  • BioSante Site #155
  • BioSante Site #221
  • BioSante Site #182
  • BioSante Site #162
  • BioSante Site #008
  • BioSante Site #159
  • BioSante Site #007
  • BioSante Site #026
  • BioSante Site #132
  • BioSante Site #151
  • BioSante Site #036
  • BioSante Site #143
  • BioSante Site #024
  • BioSante Site #111
  • BioSante Site #219
  • BioSante Site #041
  • BioSante Site #009
  • BioSante Site #115
  • BioSante Site #141
  • BioSante Site #202
  • BioSante Site #017
  • BioSante Site #189
  • BioSante Site #133
  • BioSante Site #167
  • BioSante Site #163
  • BioSante Site #214
  • BioSante Site #110
  • BioSante Site #005
  • BioSante Site #206
  • BioSante Site #035
  • BioSante Site #124
  • BioSante Site #044
  • BioSante Site #047
  • BioSante Site #105
  • BioSante Site #033
  • BioSante Site #031
  • BioSante Site #208
  • BioSante Site #198
  • BioSante Site #104
  • BioSante Site #127
  • BioSante Site #051
  • BioSante Site #006
  • BioSante Site #015
  • BioSante Site #059
  • BioSante Site #107
  • BioSante Site #131
  • BioSante Site #056
  • BioSante Site #210
  • BioSante Site #130
  • BioSante Site #212
  • BioSante Site #101
  • BioSante Site #213
  • BioSante Site #160
  • BioSante Site #153
  • BioSante Site #138
  • BioSante Site #129
  • BioSante Site #050
  • BioSante Site #106
  • BioSante Site #126
  • BioSante Site #165
  • BioSante Site #099
  • BioSante Site #197
  • BioSante Site #117
  • BioSante Site #089
  • BioSante Site #209
  • BioSante Site #049
  • BioSante Site #069
  • BioSante Site #078
  • BioSante Site #042
  • BioSante Site #120
  • BioSante Site #048
  • BioSante Site #073
  • BioSante Site #220
  • BioSante Site #147
  • BioSante Site #039
  • BioSante Site #122
  • BioSante Site #154
  • BioSante Site #211
  • BioSante Site #218
  • BioSante Site #144
  • BioSante Site #102
  • BioSante Site #096
  • BioSante Site #003
  • BioSante Site #086
  • BioSante Site #053
  • BioSante Site #083
  • BioSante Site #128
  • BioSante Site #181
  • BioSante Site #183
  • BioSante Site# 123
  • BioSante Site #188
  • BioSante Site #054
  • BioSante Site #193

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo gel

testosterone gel

Arm Description

placebo transdermal gel

transdermal testosterone gel

Outcomes

Primary Outcome Measures

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
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

Secondary Outcome Measures

change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study
This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
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
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

Full Information

First Posted
November 4, 2010
Last Updated
January 4, 2013
Sponsor
BioSante Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01235754
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioSante Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
testosterone, hypoactive sexual desire disorder, menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
626 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo gel
Arm Type
Placebo Comparator
Arm Description
placebo transdermal gel
Arm Title
testosterone gel
Arm Type
Experimental
Arm Description
transdermal testosterone gel
Intervention Type
Drug
Intervention Name(s)
transdermal testosterone gel 1%
Other Intervention Name(s)
LibiGel transdermal testosterone gel 1%
Intervention Description
300 mcg once daily transdermal testosterone gel 1%
Intervention Type
Drug
Intervention Name(s)
placebo gel
Other Intervention Name(s)
transdermal placebo gel
Intervention Description
once daily transdermal placebo gel
Primary Outcome Measure Information:
Title
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
Description
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study
Description
This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Time Frame
12 weeks
Title
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
Description
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Snabes, MD, PhD
Organizational Affiliation
BioSante Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
BioSante Site #095
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
BioSante Site #014
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
BioSante Site #146
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
BioSante Site #171
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
BioSante Site #145
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
BioSante Site #027
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
BioSante Site #121
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
BioSante Site #137
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
BioSante Site #052
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
BioSante Site #155
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
BioSante Site #221
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
BioSante Site #182
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
BioSante Site #162
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
BioSante Site #008
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
BioSante Site #159
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
BioSante Site #007
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
BioSante Site #026
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
BioSante Site #132
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
BioSante Site #151
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
BioSante Site #036
City
Ridgefield
State/Province
Connecticut
ZIP/Postal Code
06877
Country
United States
Facility Name
BioSante Site #143
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
BioSante Site #024
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
BioSante Site #111
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
BioSante Site #219
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
BioSante Site #041
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
BioSante Site #009
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
BioSante Site #115
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
BioSante Site #141
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
BioSante Site #202
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
BioSante Site #017
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
BioSante Site #189
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
BioSante Site #133
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
BioSante Site #167
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
BioSante Site #163
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
BioSante Site #214
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
BioSante Site #110
City
Metarie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
BioSante Site #005
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
BioSante Site #206
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
BioSante Site #035
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
BioSante Site #124
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
BioSante Site #044
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
BioSante Site #047
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
BioSante Site #105
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
BioSante Site #033
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
BioSante Site #031
City
St. Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
BioSante Site #208
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
BioSante Site #198
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55108
Country
United States
Facility Name
BioSante Site #104
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
BioSante Site #127
City
Billings
State/Province
Montana
ZIP/Postal Code
49101
Country
United States
Facility Name
BioSante Site #051
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
BioSante Site #006
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
BioSante Site #015
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
BioSante Site #059
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
BioSante Site #107
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
BioSante Site #131
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
BioSante Site #056
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
BioSante Site #210
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
BioSante Site #130
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
BioSante Site #212
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
BioSante Site #101
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
BioSante Site #213
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
BioSante Site #160
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
BioSante Site #153
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
Facility Name
BioSante Site #138
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
BioSante Site #129
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
BioSante Site #050
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
BioSante Site #106
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
BioSante Site #126
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
BioSante Site #165
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
BioSante Site #099
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
BioSante Site #197
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
BioSante Site #117
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
BioSante Site #089
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
BioSante Site #209
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
BioSante Site #049
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
BioSante Site #069
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
87404
Country
United States
Facility Name
BioSante Site #078
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
BioSante Site #042
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
BioSante Site #120
City
North Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
BioSante Site #048
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
BioSante Site #073
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
BioSante Site #220
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
BioSante Site #147
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
BioSante Site #039
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
BioSante Site #122
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
BioSante Site #154
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
BioSante Site #211
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
BioSante Site #218
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
BioSante Site #144
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
BioSante Site #102
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
BioSante Site #096
City
Williston
State/Province
Vermont
ZIP/Postal Code
05495
Country
United States
Facility Name
BioSante Site #003
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
BioSante Site #086
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
BioSante Site #053
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
BioSante Site #083
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
BioSante Site #128
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
BioSante Site #181
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
BioSante Site #183
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
BioSante Site# 123
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
BioSante Site #188
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
BioSante Site #054
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
BioSante Site #193
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

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