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

Last updated: January 4, 2013
Sponsor: BioSante Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Sexual Dysfunction

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT00657501
TESTW008
  • Ages 30-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be between the ages of 30 to 65 years

  • Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion

Exclusion Criteria:

  • A history of allergic reactions to androgens (oral or patch), topical alcohol, or anycomponent 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 AversionDisorder, Female Sexual Arousal Disorder).

  • A medical condition that could affect or interfere with sexual function

  • Using a systemic transdermal gel or cream estrogen therapy.

Study Design

Total Participants: 575
Study Start date:
March 01, 2008
Estimated Completion Date:
September 30, 2011

Connect with a study center

  • BioSante Site #175

    Vancouver, British Columbia V6H 3X8
    Canada

    Site Not Available

  • BioSante Site #123

    Ottawa, Ontario K1H 7W9
    Canada

    Site Not Available

  • BioSante Site #109

    Quebec City, Quebec G1S 2L6
    Canada

    Site Not Available

  • BioSante Site #146

    Mobile, Alabama 36608
    United States

    Site Not Available

  • BioSante Site #171

    Chandler, Arizona 85224
    United States

    Site Not Available

  • BioSante Site #145

    Glendale, Arizona 85306
    United States

    Site Not Available

  • BioSante Site #121

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • BioSante Site #137

    Tucson, Arizona 85710
    United States

    Site Not Available

  • BioSante Site #100

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • BioSante Site #155

    Little Rock, Arkansas 72223
    United States

    Site Not Available

  • BioSante Site #221

    Berkely, California 94705
    United States

    Site Not Available

  • BioSante Site #162

    Sacramento, California 95821
    United States

    Site Not Available

  • BioSante Site #112

    San Diego, California 92103
    United States

    Site Not Available

  • BioSante Site #159

    Walnut Creek, California 94598
    United States

    Site Not Available

  • BioSante Site #026

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • BioSante Site #166

    Farmington, Connecticut 06032
    United States

    Site Not Available

  • BioSante Site #103

    Hartford, Connecticut 06105
    United States

    Site Not Available

  • BioSante Site #132

    New Britain, Connecticut 06050
    United States

    Site Not Available

  • BioSante Site #151

    New London, Connecticut 06320
    United States

    Site Not Available

  • BioSante Site #143

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • BioSante Site #111

    Orlando, Florida 32806
    United States

    Site Not Available

  • BioSante Site #152

    Tampa, Florida 33613
    United States

    Site Not Available

  • BioSante Site #115

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • BioSante Site #141

    Roswell, Georgia 30075
    United States

    Site Not Available

  • BioSante Site #202

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • BioSante Site #017

    Meridian, Idaho 83642
    United States

    Site Not Available

  • BioSante Site #156

    Champaign, Illinois 61820
    United States

    Site Not Available

  • BioSante Site #045

    Chicago, Illinois 60611
    United States

    Site Not Available

  • BioSante Site #133

    Chicago, Illinois 60654
    United States

    Site Not Available

  • BioSante Site #149

    Chicago, Illinois 60612
    United States

    Site Not Available

  • BioSante Site #167

    Newburgh, Indiana 47630
    United States

    Site Not Available

  • BioSante Site #163

    Overland Park, Kansas 66202
    United States

    Site Not Available

  • BioSante Site #136

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • BioSante Site #214

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • BioSante Site #157

    Mandeville, Louisiana 70471
    United States

    Site Not Available

  • BioSante Site #110

    Metarie, Louisiana 70006
    United States

    Site Not Available

  • BioSante Site #035

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • BioSante Site #124

    Bingham Farms, Michigan 48025
    United States

    Site Not Available

  • BioSante Site #105

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • BioSante Site #104

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • BioSante Site #127

    Billings, Montana 59101
    United States

    Site Not Available

  • BioSante Site #114

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • BioSante Site #161

    Purchase, New York 10577
    United States

    Site Not Available

  • BioSante Site #107

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • BioSante Site #131

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • BioSante Site #130

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • BioSante Site #101

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • BioSante Site #160

    Englewood, Ohio 45322
    United States

    Site Not Available

  • BioSante Site #153

    Gallipolis, Ohio 45631
    United States

    Site Not Available

  • Site #170

    Kettering, Ohio 45429
    United States

    Site Not Available

  • BioSante Site #116

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • BioSante Site #138

    West Chester, Ohio 45069
    United States

    Site Not Available

  • BioSante Site #129

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • BioSante Site #106

    Eugene, Oregon 97401
    United States

    Site Not Available

  • BioSante Site #126

    Medford, Oregon 97504
    United States

    Site Not Available

  • BioSante Site #203

    Portland, Oregon 97227
    United States

    Site Not Available

  • BioSante Site #165

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • BioSante Site #142

    Pittsburgh, Pennsylvania 15206
    United States

    Site Not Available

  • BioSante Site #099

    Sellersville, Pennsylvania 18960
    United States

    Site Not Available

  • BioSante Site #075

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • BioSante Site #117

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • BioSante Site #120

    North Jackson, Tennessee 38305
    United States

    Site Not Available

  • BioSante Site #147

    Dallas, Texas 75234
    United States

    Site Not Available

  • BioSante Site #122

    Houston, Texas 77054
    United States

    Site Not Available

  • BioSante Site #154

    Hurst, Texas 76054
    United States

    Site Not Available

  • BioSante Site #084

    San Antonio, Texas 78229
    United States

    Site Not Available

  • BioSante Site #144

    Pleasant Grove, Utah 84062
    United States

    Site Not Available

  • BioSante Site #102

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • BioSante Site #128

    Seattle, Washington 98105
    United States

    Site Not Available

  • BioSante Site #183

    Walla Walla, Washington 99362
    United States

    Site Not Available

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