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Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal 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 testosterone, hypoactive sexual desire disorder, menopause

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • BioSante Site #146
  • BioSante Site #171
  • BioSante Site #145
  • BioSante Site #121
  • BioSante Site #137
  • BioSante Site #100
  • BioSante Site #155
  • BioSante Site #221
  • BioSante Site #162
  • BioSante Site #112
  • BioSante Site #159
  • BioSante Site #026
  • BioSante Site #166
  • BioSante Site #132
  • BioSante Site #151
  • BioSante Site #143
  • BioSante Site #111
  • BioSante Site #152
  • BioSante Site #115
  • BioSante Site #141
  • BioSante Site #202
  • BioSante Site #017
  • BioSante Site #156
  • BioSante Site #045
  • BioSante Site #149
  • BioSante Site #133
  • BioSante Site #167
  • BioSante Site #163
  • BioSante Site #214
  • BioSante Site #136
  • BioSante Site #157
  • BioSante Site #110
  • BioSante Site #035
  • BioSante Site #124
  • BioSante Site #105
  • BioSante Site #104
  • BioSante Site #127
  • BioSante Site #114
  • BioSante Site #161
  • BioSante Site #107
  • BioSante Site #131
  • BioSante Site #130
  • BioSante Site #101
  • BioSante Site #160
  • BioSante Site #153
  • Site #170
  • BioSante Site #116
  • BioSante Site #138
  • BioSante Site #129
  • BioSante Site #106
  • BioSante Site #126
  • BioSante Site #203
  • BioSante Site #165
  • BioSante Site #142
  • BioSante Site #099
  • BioSante Site #075
  • BioSante Site #117
  • BioSante Site #120
  • BioSante Site #147
  • BioSante Site #122
  • BioSante Site #154
  • BioSante Site #084
  • BioSante Site #144
  • BioSante Site #102
  • BioSante Site #128
  • BioSante Site #183
  • BioSante Site #175
  • BioSante Site #123
  • 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

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.

Secondary Outcome Measures

Change from baseline over time for multiple efficacy measurements

Full Information

First Posted
April 8, 2008
Last Updated
January 4, 2013
Sponsor
BioSante Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00657501
Brief Title
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Acronym
BLOOM
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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
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.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
575 (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 gel, 300 mcg
Intervention Type
Drug
Intervention Name(s)
placebo gel
Intervention Description
once daily transdermal placebo gel
Primary Outcome Measure Information:
Title
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.
Time Frame
Time Frame: Baseline and 21-24 weeks.
Secondary Outcome Measure Information:
Title
Change from baseline over time for multiple efficacy measurements
Time Frame
change over timepoints from baseline period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
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 #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 #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 #100
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
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
Berkely
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
BioSante Site #162
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
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 #159
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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 #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 #143
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
BioSante Site #111
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
BioSante Site #152
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
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 #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 #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 #157
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
BioSante Site #110
City
Metarie
State/Province
Louisiana
ZIP/Postal Code
70006
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 #105
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
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
59101
Country
United States
Facility Name
BioSante Site #114
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
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 #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 #130
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
BioSante Site #101
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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
Site #170
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
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 #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 #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 #120
City
North Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
BioSante Site #147
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
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 #084
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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 #128
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
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 #175
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3X8
Country
Canada
Facility Name
BioSante Site #123
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
BioSante Site #109
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.bloomstudy.com
Description
Bloomstudy.com

Learn more about this trial

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

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