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Safety and Efficacy of LibiGel® for 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 transdermal gel or cream estrogen therapy.

Locations and Contacts

BioSante Site #146, Mobile, Alabama 36608, United States

BioSante Site #171, Chandler, Arizona 85224, United States

BioSante Site #145, Glendale, Arizona 85306, United States

BioSante Site #121, Phoenix, Arizona 85015, United States

BioSante Site #137, Tucson, Arizona 85710, United States

BioSante Site #100, Jonesboro, Arkansas 72401, United States

BioSante Site #155, Little Rock, Arkansas 72223, United States

BioSante Site #175, Vancouver, British Columbia V6H 3X8, Canada

BioSante Site #221, Berkely, California 94705, United States

BioSante Site #162, Sacramento, California 95821, United States

BioSante Site #112, San Diego, California 92103, United States

BioSante Site #159, Walnut Creek, California 94598, United States

BioSante Site #026, Lakewood, Colorado 80228, United States

BioSante Site #166, Farmington, Connecticut 06032, United States

BioSante Site #132, New Britain, Connecticut 06050, United States

BioSante Site #151, New London, Connecticut 06320, United States

BioSante Site #143, Jacksonville, Florida 32216, United States

BioSante Site #111, Orlando, Florida 32806, United States

BioSante Site #152, Tampa, Florida 33613, United States

BioSante Site #115, Atlanta, Georgia 30342, United States

BioSante Site #141, Roswell, Georgia 30075, United States

BioSante Site #202, Idaho Falls, Idaho 83404, United States

BioSante Site #017, Meridian, Idaho 83642, United States

BioSante Site #156, Champaign, Illinois 61820, United States

BioSante Site #045, Chicago, Illinois 60611, United States

BioSante Site #133, Chicago, Illinois 60654, United States

BioSante Site #149, Chicago, Illinois 60612, United States

BioSante Site #167, Newburgh, Indiana 47630, United States

BioSante Site #163, Overland Park, Kansas 66202, United States

BioSante Site #136, Lexington, Kentucky 40536, United States

BioSante Site #214, Lexington, Kentucky 40504, United States

BioSante Site #157, Mandeville, Louisiana 70471, United States

BioSante Site #110, Metarie, Louisiana 70006, United States

BioSante Site #035, Ann Arbor, Michigan 48106, United States

BioSante Site #124, Bingham Farms, Michigan 48025, United States

BioSante Site #105, Kalamazoo, Michigan 49009, United States

BioSante Site #104, St. Louis, Missouri 63141, United States

BioSante Site #127, Billings, Montana 59101, United States

BioSante Site #114, Las Vegas, Nevada 89148, United States

BioSante Site #161, Purchase, New York 10577, United States

BioSante Site #107, Raleigh, North Carolina 27612, United States

BioSante Site #131, Winston Salem, North Carolina 27103, United States

BioSante Site #130, Beachwood, Ohio 44122, United States

BioSante Site #101, Cleveland, Ohio 44122, United States

BioSante Site #160, Englewood, Ohio 45322, United States

BioSante Site #153, Gallipolis, Ohio 45631, United States

Site #170, Kettering, Ohio 45429, United States

BioSante Site #116, Mayfield Heights, Ohio 44124, United States

BioSante Site #138, West Chester, Ohio 45069, United States

BioSante Site #129, Tulsa, Oklahoma 74104, United States

BioSante Site #123, Ottawa, Ontario K1H 7W9, Canada

BioSante Site #106, Eugene, Oregon 97401, United States

BioSante Site #126, Medford, Oregon 97504, United States

BioSante Site #203, Portland, Oregon 97227, United States

BioSante Site #165, Jenkintown, Pennsylvania 19046, United States

BioSante Site #142, Pittsburgh, Pennsylvania 15206, United States

BioSante Site #099, Sellersville, Pennsylvania 18960, United States

BioSante Site #109, Quebec City, Quebec G1S 2L6, Canada

BioSante Site #075, Warwick, Rhode Island 02886, United States

BioSante Site #117, Anderson, South Carolina 29621, United States

BioSante Site #120, North Jackson, Tennessee 38305, United States

BioSante Site #147, Dallas, Texas 75234, United States

BioSante Site #122, Houston, Texas 77054, United States

BioSante Site #154, Hurst, Texas 76054, United States

BioSante Site #084, San Antonio, Texas 78229, United States

BioSante Site #144, Pleasant Grove, Utah 84062, United States

BioSante Site #102, Salt Lake City, Utah 84117, United States

BioSante Site #128, Seattle, Washington 98105, United States

BioSante Site #183, Walla Walla, Washington 99362, United States

Additional Information

Starting date: March 2008
Last updated: January 4, 2013

Page last updated: August 23, 2015

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