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

Information source: BioSante Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoactive Sexual Desire Disorder

Intervention: testosterone gel (Drug); placebo gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: BioSante Pharmaceuticals

Official(s) and/or principal investigator(s):
Michael C Snabes, MD, PhD, Study Director, Affiliation: BioSante Pharmaceuticals, Inc.

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Change from baseline over time for multiple efficacy measurements

Eligibility

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

BioSante Site #215, Birmingham, Alabama 35209, United States

BioSante Site #095, Hoover, Alabama 35216, United States

BioSante Site #014, Huntsville, Alabama 35801, United States

BioSante Site #027, Glendale, Arizona 85308, United States

BioSante Site #040, Tucson, Arizona 85715, United States

BioSante Site #052, Hot Springs, Arkansas 71913, United States

BioSante Site #182, Buena Park, California 90620, United States

BioSante Site #008, San Diego, California 92108, United States

BioSante Site #007, Denver, Colorado 80218, United States

BioSante Site #216, Denver, Colorado 80239, United States

BioSante Site #036, Ridgefield, Connecticut 06877, United States

BioSante Site #013, Washington, District of Columbia 20036, United States

BioSante Site #024, Miami, Florida 33126, United States

BioSante Site #219, Pinellas Park, Florida 33781, United States

BioSante Site #041, St. Petersburg, Florida 33709, United States

BioSante Site #009, West Palm Beach, Florida 33409, United States

BioSante Site #189, Addison, Illinois 60101, United States

BioSante Site #005, Shreveport, Louisiana 71115, United States

BioSante Site #004, Baltimore, Maryland 21285, United States

BioSante Site #044, Detroit, Michigan 48201, United States

BioSante Site #047, Grand Rapids, Michigan 49503, United States

BioSante Site #033, Saginaw, Michigan 48604, United States

BioSante Site #031, St. Clair Shores, Michigan 48081, United States

BioSante Site #208, Edina, Minnesota 55435, United States

BioSante Site #198, St. Paul, Minnesota 55108, United States

BioSante Site #051, Missoula, Montana 59808, United States

BioSante Site #006, Lincoln, Nebraska 68501, United States

BioSante Site #217, Las Vegas, Nevada 89146, United States

BioSante Site #015, Poughkeepsie, New York 12601, United States

BioSante Site #059, Cary, North Carolina 27518, United States

BioSante Site #079, Charlotte, North Carolina 28209, United States

BioSante Site #061, Winston-Salem, North Carolina 27103, United States

BioSante Site #056, Fargo, North Dakota 58103, United States

BioSante Site #210, Akron, Ohio 44311, United States

BioSante Site #212, Cincinnati, Ohio 45249, United States

BioSante Site #213, Columbus, Ohio 43212, United States

BioSante Site #188, Sarnia, Ontario N7T 4X3, Canada

BioSante Site #054, Windsor, Ontario N8W5L7, Canada

BioSante Site #050, Eugene, Oregon 97401, United States

BioSante Site #197, Wexford, Pennsylvania 15090, United States

BioSante Site #193, Shawinigan, Quebec G9N 2H6, Canada

BioSante Site #089, Columbia, South Carolina 29201, United States

BioSante Site #209, Greer, South Carolina 29651, United States

BioSante Site #097, Hilton Head Island, South Carolina 29926, United States

BioSante Site #038, Mount Pleasant, South Carolina 29464, United States

BioSante Site #049, Watertown, South Dakota 57201, United States

BioSante Site #093, Bristol, Tennessee 37620, United States

BioSante Site #069, Chattanooga, Tennessee 37404, United States

BioSante Site #078, Memphis, Tennessee 38120, United States

BioSante Site #042, Nashville, Tennessee 37203, United States

BioSante Site #048, Austin, Texas 78705, United States

BioSante Site #073, Corpus Christi, Texas 78414, United States

BioSane Site #220, Dallas, Texas 75231, United States

BioSante Site #039, Houston, Texas 77054, United States

BioSante Site #211, San Antonio, Texas 78229, United States

BioSante Site #218, Murray, Utah 84123, United States

BioSante Site #096, Williston, Vermont 05495, United States

BioSante Site #003, Charlottesville, Virginia 22903, United States

BioSante Site #086, Norfolk, Virginia 23502, United States

BioSante Site #053, Richmond, Virginia 23294, United States

BioSante Site #090, Virginia Beach, Virginia 23456, United States

BioSante Site #083, Mountlake Terrace, Washington 98043, United States

BioSante Site #181, Tacoma, Washington 98405, United States

Additional Information

Starting date: December 2006
Last updated: January 4, 2013

Page last updated: August 23, 2015

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