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Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (BLOOM)

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
testosterone gel
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 Cardiovascular event, Breast Cancer, Testosterone, Menopause, Hypoactive Sexual Desire Disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • BioSante Site #215
  • BioSante Site 185
  • BioSante Site 095
  • BioSante Site #014
  • BioSante Site 196
  • BioSante Site 146
  • BioSante Site 171
  • BioSante Site 145
  • BioSante Site 027
  • BioSante Site 121
  • BioSante Site 137
  • BioSante Site 040
  • BioSante Site 052
  • BioSante Site 100
  • BioSante Site #060
  • BioSante Site 155
  • BioSante Site 011
  • BioSante Site 094
  • BioSante Site 043
  • BioSante Site 162
  • BioSante Site 025
  • BioSante Site 112
  • BioSante Site 008
  • BioSante Site #070
  • BioSante Site 205
  • BioSante Site #192
  • BioSante Site 159
  • BioSante Site 007
  • BioSante Site 216
  • BioSante Site 026
  • BioSante Site 166
  • BioSante Site 103
  • BioSante Site 132
  • BioSante Site 151
  • BioSante Site 036
  • BioSante Site 013
  • BioSante Site 118
  • BioSante Site 139
  • BioSante Site 143
  • BioSante Site 180
  • BioSante Site 024
  • BioSante Site #219
  • BioSante Site 041
  • BioSante Site 152
  • BioSante Site 009
  • BioSante Site 115
  • BioSante Site 017
  • BioSante Site 189
  • BioSante Site 156
  • BioSante Site 045
  • BioSante Site 149
  • BioSante Site 133
  • BioSante Site 167
  • BioSante Site 022
  • BioSante Site 163
  • BioSante Site #214
  • Biosante Site #136
  • BioSante Site 005
  • BioSante Site 004
  • BioSante Site 195
  • BioSante Site 066
  • 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 081
  • BioSante Site 104
  • BioSante Site 127
  • BioSante Site 051
  • BioSante Site 006
  • BioSante Site 018
  • BioSante Site #217
  • BioSante Site 125
  • BioSante Site 179
  • BioSante Site 019
  • BioSante Site 015
  • BioSante Site 161
  • BioSante Site 079
  • BioSante Site 072
  • BioSante Site 107
  • BioSante Site 034
  • BioSante Site 058
  • BioSante Site 061
  • BioSante Site 131
  • BioSante Site 056
  • BioSante Site 071
  • BioSante Site #210
  • BioSante Site #130
  • BioSante Site #212
  • BioSante Site 101
  • BioSante Site #213
  • BioSante Site 160
  • BioSante Site 153
  • BioSante Site 116
  • BioSante Site 138
  • BioSante Site 129
  • BioSante Site #050
  • BioSante Site #106
  • BioSante Site 126
  • BioSante Site #203
  • BioSante Site 165
  • BioSante Site 142
  • BioSante Site 099
  • BioSante Site 074
  • BioSante Site 075
  • BioSante Site 117
  • BioSante Site 089
  • BioSante Site #209
  • BioSante Site 097
  • BioSante Site 038
  • BioSante Site 093
  • BioSante Site 069
  • BioSante Site 002
  • BioSante Site 078
  • BioSante Site 042
  • 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 084
  • BioSante Site #218
  • BioSante Site 102
  • BioSante Site 168
  • BioSante Site 096
  • BioSante Site 003
  • BioSante Site 086
  • BioSante Site 053
  • BioSante Site 090
  • BioSante Site #083
  • BioSante Site 128
  • BioSante Site #158
  • BioSante Site #175
  • BioSante Site #164
  • BioSante Site 190
  • BioSante Site #088
  • BioSante Site 088
  • BioSante Site 188
  • BioSante Site 054
  • BioSante Site 109

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

testosterone gel

placebo gel

Arm Description

1% testosterone transdermal gel

placebo transdermal gel

Outcomes

Primary Outcome Measures

The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2008
Last Updated
October 27, 2021
Sponsor
BioSante Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00612742
Brief Title
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Acronym
BLOOM
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
Cardiovascular event, Breast Cancer, Testosterone, Menopause, Hypoactive Sexual Desire Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
testosterone gel
Arm Type
Experimental
Arm Description
1% testosterone transdermal gel
Arm Title
placebo gel
Arm Type
Placebo Comparator
Arm Description
placebo transdermal gel
Intervention Type
Drug
Intervention Name(s)
testosterone gel
Other Intervention Name(s)
LibiGel
Intervention Description
once daily transdermal testosterone gel, 300 mcg
Intervention Type
Drug
Intervention Name(s)
placebo gel
Intervention Description
once daily transdermal placebo gel
Primary Outcome Measure Information:
Title
The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
Time Frame
2011 primary outcome analysis for NDA submission

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Snabes, MD, PhD
Organizational Affiliation
BioSante Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
BioSante Site #215
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
BioSante Site 185
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
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 196
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
BioSante Site 146
City
Mobile
State/Province
Alabama
ZIP/Postal Code
33608
Country
United States
Facility Name
BioSante Site 171
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85244
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 040
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
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 100
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
BioSante Site #060
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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 011
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
BioSante Site 094
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
BioSante Site 043
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
BioSante Site 162
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
BioSante Site 025
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
BioSante Site 112
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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 #070
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
BioSante Site 205
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
BioSante Site #192
City
San Diego
State/Province
California
ZIP/Postal Code
92128
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 216
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
BioSante Site 026
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
BioSante Site 166
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
BioSante Site 103
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
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 013
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
BioSante Site 118
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
BioSante Site 139
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
BioSante Site 143
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
BioSante Site 180
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
BioSante Site 024
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
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
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
BioSante Site 152
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
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 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 156
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
BioSante Site 045
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
BioSante Site 149
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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 022
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
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 #136
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
BioSante Site 005
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
BioSante Site 004
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
BioSante Site 195
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
BioSante Site 066
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
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
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
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
Saint 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
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55108
Country
United States
Facility Name
BioSante Site 081
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
BioSante Site 104
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
BioSante Site 127
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
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 018
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
BioSante Site #217
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
BioSante Site 125
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
BioSante Site 179
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
BioSante Site 019
City
New York
State/Province
New York
ZIP/Postal Code
10016
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 161
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States
Facility Name
BioSante Site 079
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
BioSante Site 072
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
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 034
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
BioSante Site 058
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
BioSante Site 061
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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 071
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
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 116
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
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 #203
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
BioSante Site 165
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
BioSante Site 142
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
BioSante Site 099
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
BioSante Site 074
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
BioSante Site 075
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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 097
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
BioSante Site 038
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
BioSante Site 093
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
BioSante Site 069
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
BioSante Site 002
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38139
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 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
73229
Country
United States
Facility Name
BioSante Site 084
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 102
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
BioSante Site 168
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
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 090
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
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 #158
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
BioSante Site #175
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
BioSante Site #164
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
BioSante Site 190
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
BioSante Site #088
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
BioSante Site 088
City
NewMarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
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 109
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22172433
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.
Results Reference
derived
Links:
URL
http://www.bloomstudy.com
Description
www.Bloom study.com Click here for more information about this study: Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Learn more about this trial

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

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