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

October 27, 2021 updated by: BioSante Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3656

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • BioSante Site #175
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • BioSante Site #164
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1K7
        • BioSante Site 190
      • NewMarket, Ontario, Canada, L3Y 5G8
        • BioSante Site 088
      • Newmarket, Ontario, Canada, L3Y 5G8
        • BioSante Site #088
      • Sarnia, Ontario, Canada, N7T 4X3
        • BioSante Site 188
      • Windsor, Ontario, Canada, N8W 5L7
        • BioSante Site 054
    • Quebec
      • Quebec City, Quebec, Canada, G1S 2L6
        • BioSante Site 109
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • BioSante Site #215
      • Birmingham, Alabama, United States, 35233
        • BioSante Site 185
      • Hoover, Alabama, United States, 35216
        • BioSante Site 095
      • Huntsville, Alabama, United States, 35801
        • BioSante Site #014
      • Huntsville, Alabama, United States, 35802
        • BioSante Site 196
      • Mobile, Alabama, United States, 33608
        • BioSante Site 146
    • Arizona
      • Chandler, Arizona, United States, 85244
        • BioSante Site 171
      • Glendale, Arizona, United States, 85306
        • BioSante Site 145
      • Glendale, Arizona, United States, 85308
        • BioSante Site 027
      • Phoenix, Arizona, United States, 85015
        • BioSante Site 121
      • Tucson, Arizona, United States, 85710
        • BioSante Site 137
      • Tucson, Arizona, United States, 85715
        • BioSante Site 040
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • BioSante Site 052
      • Jonesboro, Arkansas, United States, 72401
        • BioSante Site 100
      • Little Rock, Arkansas, United States, 72205
        • BioSante Site #060
      • Little Rock, Arkansas, United States, 72223
        • BioSante Site 155
    • California
      • Los Angeles, California, United States, 90048
        • BioSante Site 011
      • Palm Springs, California, United States, 92262
        • BioSante Site 094
      • Roseville, California, United States, 95661
        • BioSante Site 043
      • Sacramento, California, United States, 95821
        • BioSante Site 162
      • Sacramento, California, United States, 95825
        • BioSante Site 025
      • San Diego, California, United States, 92103
        • BioSante Site 112
      • San Diego, California, United States, 92108
        • BioSante Site 008
      • San Diego, California, United States, 92120
        • BioSante Site #070
      • San Diego, California, United States, 92120
        • BioSante Site 205
      • San Diego, California, United States, 92128
        • BioSante Site #192
      • Walnut Creek, California, United States, 94598
        • BioSante Site 159
    • Colorado
      • Denver, Colorado, United States, 80218
        • BioSante Site 007
      • Denver, Colorado, United States, 80239
        • BioSante Site 216
      • Lakewood, Colorado, United States, 80228
        • BioSante Site 026
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • BioSante Site 166
      • Hartford, Connecticut, United States, 06105
        • BioSante Site 103
      • New Britain, Connecticut, United States, 06050
        • BioSante Site 132
      • New London, Connecticut, United States, 06320
        • BioSante Site 151
      • Ridgefield, Connecticut, United States, 06877
        • BioSante Site 036
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • BioSante Site 013
    • Florida
      • Aventura, Florida, United States, 33180
        • BioSante Site 118
      • Crystal River, Florida, United States, 34429
        • BioSante Site 139
      • Jacksonville, Florida, United States, 32216
        • BioSante Site 143
      • Melbourne, Florida, United States, 32935
        • BioSante Site 180
      • Miami, Florida, United States, 33126
        • BioSante Site 024
      • Pinellas Park, Florida, United States, 33781
        • BioSante Site #219
      • Saint Petersburg, Florida, United States, 33709
        • BioSante Site 041
      • Tampa, Florida, United States, 33613
        • BioSante Site 152
      • West Palm Beach, Florida, United States, 33409
        • BioSante Site 009
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • BioSante Site 115
    • Idaho
      • Meridian, Idaho, United States, 83642
        • BioSante Site 017
    • Illinois
      • Addison, Illinois, United States, 60101
        • BioSante Site 189
      • Champaign, Illinois, United States, 61820
        • BioSante Site 156
      • Chicago, Illinois, United States, 60611
        • BioSante Site 045
      • Chicago, Illinois, United States, 60612
        • BioSante Site 149
      • Chicago, Illinois, United States, 60654
        • BioSante Site 133
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • BioSante Site 167
      • South Bend, Indiana, United States, 46601
        • BioSante Site 022
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • BioSante Site 163
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • BioSante Site #214
      • Lexington, Kentucky, United States, 40536
        • BioSante Site #136
    • Louisiana
      • Shreveport, Louisiana, United States, 71115
        • BioSante Site 005
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • BioSante Site 004
      • Greenbelt, Maryland, United States, 20770
        • BioSante Site 195
      • Rockville, Maryland, United States, 20850
        • BioSante Site 066
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • BioSante Site #206
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • BioSante Site 035
      • Bingham Farms, Michigan, United States, 48025
        • BioSante Site 124
      • Detroit, Michigan, United States, 48201
        • BioSante Site 044
      • Grand Rapids, Michigan, United States, 49503
        • BioSante Site 047
      • Paw Paw, Michigan, United States, 49079
        • BioSante Site 105
      • Saginaw, Michigan, United States, 48604
        • BioSante Site 033
      • Saint Clair Shores, Michigan, United States, 48081
        • BioSante Site 031
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • BioSante Site #208
      • Saint Paul, Minnesota, United States, 55108
        • BioSante Site 198
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • BioSante Site 081
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • BioSante Site 104
    • Montana
      • Billings, Montana, United States, 59101
        • BioSante Site 127
      • Missoula, Montana, United States, 59808
        • BioSante Site 051
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • BioSante Site 006
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • BioSante Site #217
      • Las Vegas, Nevada, United States, 89128
        • BioSante Site 018
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • BioSante Site 125
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • BioSante Site 179
    • New York
      • New York, New York, United States, 10016
        • BioSante Site 019
      • Poughkeepsie, New York, United States, 12601
        • BioSante Site 015
      • Purchase, New York, United States, 10577
        • BioSante Site 161
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • BioSante Site 079
      • Hickory, North Carolina, United States, 28601
        • BioSante Site 072
      • Raleigh, North Carolina, United States, 27612
        • BioSante Site 107
      • Winston-Salem, North Carolina, United States, 27103
        • BioSante Site 034
      • Winston-Salem, North Carolina, United States, 27103
        • BioSante Site 058
      • Winston-Salem, North Carolina, United States, 27103
        • BioSante Site 061
      • Winston-Salem, North Carolina, United States, 27103
        • BioSante Site 131
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • BioSante Site 056
      • Minot, North Dakota, United States, 58701
        • BioSante Site 071
    • Ohio
      • Akron, Ohio, United States, 44311
        • BioSante Site #210
      • Beachwood, Ohio, United States, 44122
        • BioSante Site #130
      • Cincinnati, Ohio, United States, 45249
        • BioSante Site #212
      • Cleveland, Ohio, United States, 44122
        • BioSante Site 101
      • Columbus, Ohio, United States, 43212
        • BioSante Site #213
      • Englewood, Ohio, United States, 45322
        • BioSante Site 160
      • Gallipolis, Ohio, United States, 45631
        • BioSante Site 153
      • Mayfield Heights, Ohio, United States, 44124
        • BioSante Site 116
      • West Chester, Ohio, United States, 45069
        • BioSante Site 138
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • BioSante Site 129
    • Oregon
      • Eugene, Oregon, United States, 97401
        • BioSante Site #050
      • Eugene, Oregon, United States, 97401
        • BioSante Site #106
      • Medford, Oregon, United States, 97504
        • BioSante Site 126
      • Portland, Oregon, United States, 97227
        • BioSante Site #203
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • BioSante Site 165
      • Pittsburgh, Pennsylvania, United States, 15206
        • BioSante Site 142
      • Sellersville, Pennsylvania, United States, 18960
        • BioSante Site 099
      • West Reading, Pennsylvania, United States, 19611
        • BioSante Site 074
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • BioSante Site 075
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • BioSante Site 117
      • Columbia, South Carolina, United States, 29201
        • BioSante Site 089
      • Greer, South Carolina, United States, 29651
        • BioSante Site #209
      • Hilton Head Island, South Carolina, United States, 29926
        • BioSante Site 097
      • Mount Pleasant, South Carolina, United States, 29464
        • BioSante Site 038
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • BioSante Site 093
      • Chattanooga, Tennessee, United States, 37404
        • BioSante Site 069
      • Germantown, Tennessee, United States, 38139
        • BioSante Site 002
      • Memphis, Tennessee, United States, 38120
        • BioSante Site 078
      • Nashville, Tennessee, United States, 37203
        • BioSante Site 042
    • Texas
      • Austin, Texas, United States, 78705
        • BioSante Site 048
      • Corpus Christi, Texas, United States, 78414
        • BioSante Site 073
      • Dallas, Texas, United States, 75231
        • BioSante Site #220
      • Dallas, Texas, United States, 75234
        • BioSante Site 147
      • Houston, Texas, United States, 77054
        • BioSante Site 039
      • Houston, Texas, United States, 77054
        • BioSante Site 122
      • Hurst, Texas, United States, 76054
        • BioSante Site 154
      • San Antonio, Texas, United States, 73229
        • BioSante Site #211
      • San Antonio, Texas, United States, 78229
        • BioSante Site 084
    • Utah
      • Murray, Utah, United States, 84123
        • BioSante Site #218
      • Salt Lake City, Utah, United States, 84117
        • BioSante Site 102
      • Sandy, Utah, United States, 84070
        • BioSante Site 168
    • Vermont
      • Williston, Vermont, United States, 05495
        • BioSante Site 096
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • BioSante Site 003
      • Norfolk, Virginia, United States, 23502
        • BioSante Site 086
      • Richmond, Virginia, United States, 23294
        • BioSante Site 053
      • Virginia Beach, Virginia, United States, 23456
        • BioSante Site 090
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • BioSante Site #083
      • Seattle, Washington, United States, 98105
        • BioSante Site 128
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • BioSante Site #158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: testosterone gel
1% testosterone transdermal gel
Drug: testosterone gel
once daily transdermal testosterone gel, 300 mcg
Other Names:
  • LibiGel
Placebo Comparator: placebo gel
placebo transdermal gel
Drug: placebo gel
once daily transdermal placebo gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2011 primary outcome analysis for NDA submission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSante Pharmaceuticals

Investigators

  • Study Director: Michael C Snabes, MD, PhD, BioSante Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESTW007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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