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

January 4, 2013 updated by: BioSante Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

597

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
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • BioSante Site #188
      • Windsor, Ontario, Canada, N8W5L7
        • BioSante Site #054
    • Quebec
      • Shawinigan, Quebec, Canada, G9N 2H6
        • BioSante Site #193
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • BioSante Site #215
      • Hoover, Alabama, United States, 35216
        • BioSante Site #095
      • Huntsville, Alabama, United States, 35801
        • BioSante Site #014
    • Arizona
      • Glendale, Arizona, United States, 85308
        • BioSante Site #027
      • Tucson, Arizona, United States, 85715
        • BioSante Site #040
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • BioSante Site #052
    • California
      • Buena Park, California, United States, 90620
        • BioSante Site #182
      • San Diego, California, United States, 92108
        • BioSante Site #008
    • Colorado
      • Denver, Colorado, United States, 80218
        • BioSante Site #007
      • Denver, Colorado, United States, 80239
        • BioSante Site #216
    • Connecticut
      • Ridgefield, Connecticut, United States, 06877
        • BioSante Site #036
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • BioSante Site #013
    • Florida
      • Miami, Florida, United States, 33126
        • BioSante Site #024
      • Pinellas Park, Florida, United States, 33781
        • BioSante Site #219
      • St. Petersburg, Florida, United States, 33709
        • BioSante Site #041
      • West Palm Beach, Florida, United States, 33409
        • BioSante Site #009
    • Illinois
      • Addison, Illinois, United States, 60101
        • BioSante Site #189
    • Louisiana
      • Shreveport, Louisiana, United States, 71115
        • BioSante Site #005
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • BioSante Site #004
    • Michigan
      • Detroit, Michigan, United States, 48201
        • BioSante Site #044
      • Grand Rapids, Michigan, United States, 49503
        • BioSante Site #047
      • Saginaw, Michigan, United States, 48604
        • BioSante Site #033
      • St. Clair Shores, Michigan, United States, 48081
        • BioSante Site #031
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • BioSante Site #208
      • St. Paul, Minnesota, United States, 55108
        • BioSante Site #198
    • Montana
      • Missoula, Montana, United States, 59808
        • BioSante Site #051
    • Nebraska
      • Lincoln, Nebraska, United States, 68501
        • BioSante Site #006
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • BioSante Site #217
    • New York
      • Poughkeepsie, New York, United States, 12601
        • BioSante Site #015
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • BioSante Site #059
      • Charlotte, North Carolina, United States, 28209
        • BioSante Site #079
      • Winston-Salem, North Carolina, United States, 27103
        • BioSante Site #061
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • BioSante Site #056
    • Ohio
      • Akron, Ohio, United States, 44311
        • BioSante Site #210
      • Cincinnati, Ohio, United States, 45249
        • BioSante Site #212
      • Columbus, Ohio, United States, 43212
        • BioSante Site #213
    • Oregon
      • Eugene, Oregon, United States, 97401
        • BioSante Site #050
    • Pennsylvania
      • Wexford, Pennsylvania, United States, 15090
        • BioSante Site #197
    • South Carolina
      • 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
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • BioSante Site #049
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • BioSante Site #093
      • Chattanooga, Tennessee, United States, 37404
        • BioSante Site #069
      • 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
        • BioSane Site #220
      • Houston, Texas, United States, 77054
        • BioSante Site #039
      • San Antonio, Texas, United States, 78229
        • BioSante Site #211
    • Utah
      • Murray, Utah, United States, 84123
        • BioSante Site #218
    • 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
      • Tacoma, Washington, United States, 98405
        • BioSante Site #181

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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
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.
Baseline and 21-24 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline over time for multiple efficacy measurements
Time Frame: change over timepoints from baseline
change over timepoints from baseline

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.

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

December 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESTW006

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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