Safety and Efficacy of LibiGel® for the 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

NCT00613002
TESTW006
  • 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 topical gel or cream estrogen therapy.

Study Design

Total Participants: 597
Study Start date:
December 01, 2006
Estimated Completion Date:
September 30, 2011

Connect with a study center

  • BioSante Site #188

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • BioSante Site #054

    Windsor, Ontario N8W5L7
    Canada

    Site Not Available

  • BioSante Site #193

    Shawinigan, Quebec G9N 2H6
    Canada

    Site Not Available

  • BioSante Site #215

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • BioSante Site #095

    Hoover, Alabama 35216
    United States

    Site Not Available

  • BioSante Site #014

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • BioSante Site #027

    Glendale, Arizona 85308
    United States

    Site Not Available

  • BioSante Site #040

    Tucson, Arizona 85715
    United States

    Site Not Available

  • BioSante Site #052

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • BioSante Site #182

    Buena Park, California 90620
    United States

    Site Not Available

  • BioSante Site #008

    San Diego, California 92108
    United States

    Site Not Available

  • BioSante Site #007

    Denver, Colorado 80218
    United States

    Site Not Available

  • BioSante Site #216

    Denver, Colorado 80239
    United States

    Site Not Available

  • BioSante Site #036

    Ridgefield, Connecticut 06877
    United States

    Site Not Available

  • BioSante Site #013

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • BioSante Site #024

    Miami, Florida 33126
    United States

    Site Not Available

  • BioSante Site #219

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • BioSante Site #041

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • BioSante Site #009

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • BioSante Site #189

    Addison, Illinois 60101
    United States

    Site Not Available

  • BioSante Site #005

    Shreveport, Louisiana 71115
    United States

    Site Not Available

  • BioSante Site #004

    Baltimore, Maryland 21285
    United States

    Site Not Available

  • BioSante Site #044

    Detroit, Michigan 48201
    United States

    Site Not Available

  • BioSante Site #047

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • BioSante Site #033

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • BioSante Site #031

    St. Clair Shores, Michigan 48081
    United States

    Site Not Available

  • BioSante Site #208

    Edina, Minnesota 55435
    United States

    Site Not Available

  • BioSante Site #198

    St. Paul, Minnesota 55108
    United States

    Site Not Available

  • BioSante Site #051

    Missoula, Montana 59808
    United States

    Site Not Available

  • BioSante Site #006

    Lincoln, Nebraska 68501
    United States

    Site Not Available

  • BioSante Site #217

    Las Vegas, Nevada 89146
    United States

    Site Not Available

  • BioSante Site #015

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • BioSante Site #059

    Cary, North Carolina 27518
    United States

    Site Not Available

  • BioSante Site #079

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • BioSante Site #061

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • BioSante Site #056

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • BioSante Site #210

    Akron, Ohio 44311
    United States

    Site Not Available

  • BioSante Site #212

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • BioSante Site #213

    Columbus, Ohio 43212
    United States

    Site Not Available

  • BioSante Site #050

    Eugene, Oregon 97401
    United States

    Site Not Available

  • BioSante Site #197

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • BioSante Site #089

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • BioSante Site #209

    Greer, South Carolina 29651
    United States

    Site Not Available

  • BioSante Site #097

    Hilton Head Island, South Carolina 29926
    United States

    Site Not Available

  • BioSante Site #038

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • BioSante Site #049

    Watertown, South Dakota 57201
    United States

    Site Not Available

  • BioSante Site #093

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • BioSante Site #069

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • BioSante Site #078

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • BioSante Site #042

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • BioSante Site #048

    Austin, Texas 78705
    United States

    Site Not Available

  • BioSante Site #073

    Corpus Christi, Texas 78414
    United States

    Site Not Available

  • BioSane Site #220

    Dallas, Texas 75231
    United States

    Site Not Available

  • BioSante Site #039

    Houston, Texas 77054
    United States

    Site Not Available

  • BioSante Site #211

    San Antonio, Texas 78229
    United States

    Site Not Available

  • BioSante Site #218

    Murray, Utah 84123
    United States

    Site Not Available

  • BioSante Site #096

    Williston, Vermont 05495
    United States

    Site Not Available

  • BioSante Site #003

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • BioSante Site #086

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • BioSante Site #053

    Richmond, Virginia 23294
    United States

    Site Not Available

  • BioSante Site #090

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • BioSante Site #083

    Mountlake Terrace, Washington 98043
    United States

    Site Not Available

  • BioSante Site #181

    Tacoma, Washington 98405
    United States

    Site Not Available

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