Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

January 4, 2013 updated by: BioSante Pharmaceuticals

A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

626

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
      • Ottawa, Ontario, Canada, K1H 7W9
        • BioSante Site# 123
      • Sarnia, Ontario, Canada, N7T 4X3
        • BioSante Site #188
      • Windsor, Ontario, Canada, N8W 5L7
        • BioSante Site #054
    • Quebec
      • Shawinigan, Quebec, Canada, G9N 2H6
        • BioSante Site #193
  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • BioSante Site #095
      • Huntsville, Alabama, United States, 35801
        • BioSante Site #014
      • Mobile, Alabama, United States, 36608
        • BioSante Site #146
    • Arizona
      • Chandler, Arizona, United States, 85224
        • BioSante Site #171
      • Glendale, Arizona, United States, 85308
        • BioSante Site #027
      • Glendale, Arizona, United States, 85306
        • BioSante Site #145
      • Phoenix, Arizona, United States, 85015
        • BioSante Site #121
      • Tucson, Arizona, United States, 85710
        • BioSante Site #137
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • BioSante Site #052
      • Little Rock, Arkansas, United States, 72223
        • BioSante Site #155
    • California
      • Berkeley, California, United States, 94705
        • BioSante Site #221
      • Buena Park, California, United States, 90620
        • BioSante Site #182
      • Sacramento, California, United States, 95821
        • BioSante Site #162
      • San Diego, California, United States, 92108
        • BioSante Site #008
      • Walnut Creek, California, United States, 94598
        • BioSante Site #159
    • Colorado
      • Denver, Colorado, United States, 80218
        • BioSante Site #007
      • Lakewood, Colorado, United States, 80239
        • BioSante Site #026
    • Connecticut
      • 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
    • Florida
      • Jacksonville, Florida, United States, 32216
        • BioSante Site #143
      • Miami, Florida, United States, 33126
        • BioSante Site #024
      • Orlando, Florida, United States, 32806
        • BioSante Site #111
      • 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
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • BioSante Site #115
      • Roswell, Georgia, United States, 30075
        • BioSante Site #141
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • BioSante Site #202
      • Meridian, Idaho, United States, 83642
        • BioSante Site #017
    • Illinois
      • Addison, Illinois, United States, 60101
        • BioSante Site #189
      • Chicago, Illinois, United States, 60654
        • BioSante Site #133
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • BioSante Site #167
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • BioSante Site #163
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • BioSante Site #214
    • Louisiana
      • Metarie, Louisiana, United States, 70006
        • BioSante Site #110
      • Shreveport, Louisiana, United States, 71115
        • BioSante Site #005
    • 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
      • Kalamazoo, Michigan, United States, 49009
        • BioSante Site #105
      • 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
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • BioSante Site #104
    • Montana
      • Billings, Montana, United States, 49101
        • BioSante Site #127
      • Missoula, Montana, United States, 59808
        • BioSante Site #051
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • BioSante Site #006
    • New York
      • Poughkeepsie, New York, United States, 12601
        • BioSante Site #015
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • BioSante Site #059
      • Raleigh, North Carolina, United States, 27612
        • BioSante Site #107
      • Winston-Salem, North Carolina, United States, 27103
        • BioSante Site #131
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • BioSante Site #056
    • 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
      • 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
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • BioSante Site #165
      • Sellersville, Pennsylvania, United States, 18960
        • BioSante Site #099
      • Wexford, Pennsylvania, United States, 15090
        • BioSante Site #197
    • 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
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • BioSante Site #049
    • Tennessee
      • Chattanooga, Tennessee, United States, 87404
        • BioSante Site #069
      • Memphis, Tennessee, United States, 38120
        • BioSante Site #078
      • Nashville, Tennessee, United States, 37203
        • BioSante Site #042
      • North Jackson, Tennessee, United States, 38305
        • BioSante Site #120
    • 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, 78229
        • BioSante Site #211
    • Utah
      • Murray, Utah, United States, 84123
        • BioSante Site #218
      • Pleasant Grove, Utah, United States, 84062
        • BioSante Site #144
      • Salt Lake City, Utah, United States, 84117
        • BioSante Site #102
    • 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
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • BioSante Site #083
      • Seattle, Washington, United States, 98105
        • BioSante Site #128
      • Tacoma, Washington, United States, 98405
        • BioSante Site #181
      • Walla Walla, Washington, United States, 99362
        • BioSante Site #183

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 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

Exclusion Criteria:

  • Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion 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: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study
Time Frame: 12 weeks
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study
Time Frame: 12 weeks
This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
12 weeks
change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study
Time Frame: 12 weeks
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
12 weeks

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

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

October 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 7, 2010

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

  • TESTW009

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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