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Safety and Efficacy of LibiGel® for the 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 hypoactive sexual desire disorder, testosterone, 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 topical gel or cream estrogen therapy.

Sites / Locations

  • BioSante Site #215
  • BioSante Site #095
  • BioSante Site #014
  • BioSante Site #027
  • BioSante Site #040
  • BioSante Site #052
  • BioSante Site #182
  • BioSante Site #008
  • BioSante Site #007
  • BioSante Site #216
  • BioSante Site #036
  • BioSante Site #013
  • BioSante Site #024
  • BioSante Site #219
  • BioSante Site #041
  • BioSante Site #009
  • BioSante Site #189
  • BioSante Site #005
  • BioSante Site #004
  • BioSante Site #044
  • BioSante Site #047
  • BioSante Site #033
  • BioSante Site #031
  • BioSante Site #208
  • BioSante Site #198
  • BioSante Site #051
  • BioSante Site #006
  • BioSante Site #217
  • BioSante Site #015
  • BioSante Site #059
  • BioSante Site #079
  • BioSante Site #061
  • BioSante Site #056
  • BioSante Site #210
  • BioSante Site #212
  • BioSante Site #213
  • BioSante Site #050
  • BioSante Site #197
  • BioSante Site #089
  • BioSante Site #209
  • BioSante Site #097
  • BioSante Site #038
  • BioSante Site #049
  • BioSante Site #093
  • BioSante Site #069
  • BioSante Site #078
  • BioSante Site #042
  • BioSante Site #048
  • BioSante Site #073
  • BioSane Site #220
  • BioSante Site #039
  • BioSante Site #211
  • BioSante Site #218
  • BioSante Site #096
  • BioSante Site #003
  • BioSante Site #086
  • BioSante Site #053
  • BioSante Site #090
  • BioSante Site #083
  • BioSante Site #181
  • BioSante Site #188
  • BioSante Site #054
  • BioSante Site #193

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
January 30, 2008
Last Updated
January 4, 2013
Sponsor
BioSante Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00613002
Brief Title
Safety and Efficacy of LibiGel® for the 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
December 2006 (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
hypoactive sexual desire disorder, testosterone, menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
597 (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
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
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

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 topical 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 #215
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
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 #027
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
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 #182
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
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 #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 #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 #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
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 #189
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
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 #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 #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 #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
68501
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 #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 #079
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
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 #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 #212
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
BioSante Site #213
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
BioSante Site #050
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
BioSante Site #197
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
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 #049
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
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 #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
BioSane Site #220
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
BioSante Site #039
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
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 #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 #181
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
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
N8W5L7
Country
Canada
Facility Name
BioSante Site #193
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada

12. IPD Sharing Statement

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

Learn more about this trial

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

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