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

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.

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

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

Primary outcome: The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: Postmenopausal female subjects

- at least 50 years of age

- with at least two points of cardiovascular risk

- with a clinical diagnosis of HSDD.

Exclusion Criteria: Subjects must not

- require treatment with anti-androgens, high-dose oral or injectable corticosteroids,

tamoxifen or other selective estrogen receptor modulators,

- have used androgen therapy within 2 months of randomization,

- have a history of estrogen-dependent neoplasia or any gynecologic cancer,

- have a history of cancer of any kind in the past 10 years prior to randomization,

- have a history of malignant melanoma or a history of invasive cancer at any time,

- have a screening mammogram with any finding that requires follow up within 6 months

of randomization,

- have a history of myocardial infarction, coronary revascularization or stroke within

12 months of randomization,

- have any medical condition associated with predicted survival of less than 3 years in

the judgment of the Investigator.

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

BioSante Site 185, Birmingham, Alabama 35233, United States

BioSante Site 095, Hoover, Alabama 35216, United States

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

BioSante Site 196, Huntsville, Alabama 35802, United States

BioSante Site 146, Mobile, Alabama 33608, United States

BioSante Site 171, Chandler, Arizona 85244, United States

BioSante Site 027, Glendale, Arizona 85308, United States

BioSante Site 145, Glendale, Arizona 85306, United States

BioSante Site 121, Phoenix, Arizona 85015, United States

BioSante Site 040, Tucson, Arizona 85715, United States

BioSante Site 137, Tucson, Arizona 85710, United States

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

BioSante Site 100, Jonesboro, Arkansas 72401, United States

BioSante Site #060, Little Rock, Arkansas 72205, United States

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

BioSante Site #175, Vancouver, British Columbia V5Z 4E1, Canada

BioSante Site 011, Los Angeles, California 90048, United States

BioSante Site 094, Palm Springs, California 92262, United States

BioSante Site 043, Roseville, California 95661, United States

BioSante Site 025, Sacramento, California 95825, United States

BioSante Site 162, Sacramento, California 95821, United States

BioSante Site #070, San Diego, California 92120, United States

BioSante Site #192, San Diego, California 92128, United States

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

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

BioSante Site 205, San Diego, California 92120, United States

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

BioSante Site 007, Denver, Colorado 80218, United States

BioSante Site 216, Denver, Colorado 80239, United States

BioSante Site 026, Lakewood, Colorado 80228, United States

BioSante Site 166, Farmington, Connecticut 06032, United States

BioSante Site 103, Hartford, Connecticut 06105, United States

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

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

BioSante Site 036, Ridgefield, Connecticut 06877, United States

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

BioSante Site 118, Aventura, Florida 33180, United States

BioSante Site 139, Crystal River, Florida 34429, United States

BioSante Site 143, Jacksonville, Florida 32216, United States

BioSante Site 180, Melbourne, Florida 32935, 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 152, Tampa, Florida 33613, United States

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

BioSante Site 115, Atlanta, Georgia 30342, United States

BioSante Site 017, Meridian, Idaho 83642, United States

BioSante Site 189, Addison, Illinois 60101, 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 022, South Bend, Indiana 46601, 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 005, Shreveport, Louisiana 71115, United States

BioSante Site #164, Winnipeg, Manitoba R3A 1M3, Canada

BioSante Site 004, Baltimore, Maryland 21285, United States

BioSante Site 195, Greenbelt, Maryland 20770, United States

BioSante Site 066, Rockville, Maryland 20850, United States

BioSante Site #206, Fall River, Massachusetts 02720, United States

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

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

BioSante Site 044, Detroit, Michigan 48201, United States

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

BioSante Site 105, Paw Paw, Michigan 49079, 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 081, Olive Branch, Mississippi 38654, United States

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

BioSante Site 127, Billings, Montana 59101, United States

BioSante Site 051, Missoula, Montana 59808, United States

BioSante Site 006, Lincoln, Nebraska 68510, United States

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

BioSante Site 018, Las Vegas, Nevada 89128, United States

BioSante Site 125, Lawrenceville, New Jersey 08648, United States

BioSante Site 179, Albuquerque, New Mexico 87109, United States

BioSante Site 019, New York, New York 10016, United States

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

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

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

BioSante Site 072, Hickory, North Carolina 28601, United States

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

BioSante Site 034, Winston-Salem, North Carolina 27103, United States

BioSante Site 058, Winston-Salem, North Carolina 27103, United States

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

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

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

BioSante Site 071, Minot, North Dakota 58701, United States

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

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

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

BioSante Site 101, Cleveland, Ohio 44122, United States

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

BioSante Site 160, Englewood, Ohio 45322, United States

BioSante Site 153, Gallipolis, Ohio 45631, 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 190, Hamilton, Ontario L8M 1K7, Canada

BioSante Site #088, Newmarket, Ontario L3Y 5G8, Canada

BioSante Site 088, NewMarket, Ontario L3Y 5G8, Canada

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

BioSante Site 054, Windsor, Ontario N8W 5L7, Canada

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

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 074, West Reading, Pennsylvania 19611, 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 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 093, Bristol, Tennessee 37620, United States

BioSante Site 069, Chattanooga, Tennessee 37404, United States

BioSante Site 002, Germantown, Tennessee 38139, 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

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

BioSante Site 147, Dallas, Texas 75234, United States

BioSante Site 039, Houston, Texas 77054, United States

BioSante Site 122, Houston, Texas 77054, United States

BioSante Site 154, Hurst, Texas 76054, United States

BioSante Site #211, San Antonio, Texas 73229, United States

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

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

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

BioSante Site 168, Sandy, Utah 84070, 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 128, Seattle, Washington 98105, United States

BioSante Site #158, Milwaukee, Wisconsin 53209, United States

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