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

NCT00612742 | Completed Phase 3 DMC

• 1 other identifier: TESTW007
• Study Type: interventional
• Target: 3,656
• Locations: 2 countries
• Sites: 149

Brief Summary

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).

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Cardiovascular event; Breast Cancer; Testosterone; Menopause; Hypoactive Sexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

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

  2011 primary outcome analysis for NDA submission

Study Arms (2)

testosterone gel

EXPERIMENTAL

1% testosterone transdermal gel

Drug: testosterone gel

placebo gel

PLACEBO COMPARATOR

placebo transdermal gel

Drug: placebo gel

Interventions

testosterone gel DRUG

once daily transdermal testosterone gel, 300 mcg

Also known as: LibiGel

testosterone gel

placebo gel DRUG

once daily transdermal placebo gel

placebo gel

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal female subjects
• at least 50 years of age
• with at least two points of cardiovascular risk
• with a clinical diagnosis of HSDD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioSante Pharmaceuticals: lead

Study Sites (149)

BioSante Site #215

Birmingham, Alabama, 35209, United States

Location

BioSante Site 185

Birmingham, Alabama, 35233, United States

Location

BioSante Site 095

Hoover, Alabama, 35216, United States

Location

BioSante Site #014

Huntsville, Alabama, 35801, United States

Location

BioSante Site 196

Huntsville, Alabama, 35802, United States

Location

BioSante Site 146

Mobile, Alabama, 33608, United States

Location

BioSante Site 171

Chandler, Arizona, 85244, United States

Location

BioSante Site 145

Glendale, Arizona, 85306, United States

Location

BioSante Site 027

Glendale, Arizona, 85308, United States

Location

BioSante Site 121

Phoenix, Arizona, 85015, United States

Location

BioSante Site 137

Tucson, Arizona, 85710, United States

Location

BioSante Site 040

Tucson, Arizona, 85715, United States

Location

BioSante Site 052

Hot Springs, Arkansas, 71913, United States

Location

BioSante Site 100

Jonesboro, Arkansas, 72401, United States

Location

BioSante Site #060

Little Rock, Arkansas, 72205, United States

Location

BioSante Site 155

Little Rock, Arkansas, 72223, United States

Location

BioSante Site 011

Los Angeles, California, 90048, United States

Location

BioSante Site 094

Palm Springs, California, 92262, United States

Location

BioSante Site 043

Roseville, California, 95661, United States

Location

BioSante Site 162

Sacramento, California, 95821, United States

Location

BioSante Site 025

Sacramento, California, 95825, United States

Location

BioSante Site 112

San Diego, California, 92103, United States

Location

BioSante Site 008

San Diego, California, 92108, United States

Location

BioSante Site #070

San Diego, California, 92120, United States

Location

BioSante Site 205

San Diego, California, 92120, United States

Location

BioSante Site #192

San Diego, California, 92128, United States

Location

BioSante Site 159

Walnut Creek, California, 94598, United States

Location

BioSante Site 007

Denver, Colorado, 80218, United States

Location

BioSante Site 216

Denver, Colorado, 80239, United States

Location

BioSante Site 026

Lakewood, Colorado, 80228, United States

Location

BioSante Site 166

Farmington, Connecticut, 06032, United States

Location

BioSante Site 103

Hartford, Connecticut, 06105, United States

Location

BioSante Site 132

New Britain, Connecticut, 06050, United States

Location

BioSante Site 151

New London, Connecticut, 06320, United States

Location

BioSante Site 036

Ridgefield, Connecticut, 06877, United States

Location

BioSante Site 013

Washington D.C., District of Columbia, 20036, United States

Location

BioSante Site 118

Aventura, Florida, 33180, United States

Location

BioSante Site 139

Crystal River, Florida, 34429, United States

Location

BioSante Site 143

Jacksonville, Florida, 32216, United States

Location

BioSante Site 180

Melbourne, Florida, 32935, United States

Location

BioSante Site 024

Miami, Florida, 33126, United States

Location

BioSante Site #219

Pinellas Park, Florida, 33781, United States

Location

BioSante Site 041

St. Petersburg, Florida, 33709, United States

Location

BioSante Site 152

Tampa, Florida, 33613, United States

Location

BioSante Site 009

West Palm Beach, Florida, 33409, United States

Location

BioSante Site 115

Atlanta, Georgia, 30342, United States

Location

BioSante Site 017

Meridian, Idaho, 83642, United States

Location

BioSante Site 189

Addison, Illinois, 60101, United States

Location

BioSante Site 156

Champaign, Illinois, 61820, United States

Location

BioSante Site 045

Chicago, Illinois, 60611, United States

Location

BioSante Site 149

Chicago, Illinois, 60612, United States

Location

BioSante Site 133

Chicago, Illinois, 60654, United States

Location

BioSante Site 167

Newburgh, Indiana, 47630, United States

Location

BioSante Site 022

South Bend, Indiana, 46601, United States

Location

BioSante Site 163

Overland Park, Kansas, 66202, United States

Location

BioSante Site #214

Lexington, Kentucky, 40504, United States

Location

Biosante Site #136

Lexington, Kentucky, 40536, United States

Location

BioSante Site 005

Shreveport, Louisiana, 71115, United States

Location

BioSante Site 004

Baltimore, Maryland, 21285, United States

Location

BioSante Site 195

Greenbelt, Maryland, 20770, United States

Location

BioSante Site 066

Rockville, Maryland, 20850, United States

Location

BioSante Site #206

Fall River, Massachusetts, 02720, United States

Location

BioSante Site 035

Ann Arbor, Michigan, 48106, United States

Location

BioSante Site 124

Bingham Farms, Michigan, 48025, United States

Location

BioSante Site 044

Detroit, Michigan, 48201, United States

Location

BioSante Site 047

Grand Rapids, Michigan, 49503, United States

Location

BioSante Site 105

Paw Paw, Michigan, 49079, United States

Location

BioSante Site 033

Saginaw, Michigan, 48604, United States

Location

BioSante Site 031

Saint Clair Shores, Michigan, 48081, United States

Location

BioSante Site #208

Edina, Minnesota, 55435, United States

Location

BioSante Site 198

Saint Paul, Minnesota, 55108, United States

Location

BioSante Site 081

Olive Branch, Mississippi, 38654, United States

Location

BioSante Site 104

St Louis, Missouri, 63141, United States

Location

BioSante Site 127

Billings, Montana, 59101, United States

Location

BioSante Site 051

Missoula, Montana, 59808, United States

Location

BioSante Site 006

Lincoln, Nebraska, 68510, United States

Location

BioSante Site 018

Las Vegas, Nevada, 89128, United States

Location

BioSante Site #217

Las Vegas, Nevada, 89146, United States

Location

BioSante Site 125

Lawrenceville, New Jersey, 08648, United States

Location

BioSante Site 179

Albuquerque, New Mexico, 87109, United States

Location

BioSante Site 019

New York, New York, 10016, United States

Location

BioSante Site 015

Poughkeepsie, New York, 12601, United States

Location

BioSante Site 161

Purchase, New York, 10577, United States

Location

BioSante Site 079

Charlotte, North Carolina, 28209, United States

Location

BioSante Site 072

Hickory, North Carolina, 28601, United States

Location

BioSante Site 107

Raleigh, North Carolina, 27612, United States

Location

BioSante Site 034

Winston-Salem, North Carolina, 27103, United States

Location

BioSante Site 058

Winston-Salem, North Carolina, 27103, United States

Location

BioSante Site 061

Winston-Salem, North Carolina, 27103, United States

Location

BioSante Site 131

Winston-Salem, North Carolina, 27103, United States

Location

BioSante Site 056

Fargo, North Dakota, 58103, United States

Location

BioSante Site 071

Minot, North Dakota, 58701, United States

Location

BioSante Site #210

Akron, Ohio, 44311, United States

Location

BioSante Site #130

Beachwood, Ohio, 44122, United States

Location

BioSante Site #212

Cincinnati, Ohio, 45249, United States

Location

BioSante Site 101

Cleveland, Ohio, 44122, United States

Location

BioSante Site #213

Columbus, Ohio, 43212, United States

Location

BioSante Site 160

Englewood, Ohio, 45322, United States

Location

BioSante Site 153

Gallipolis, Ohio, 45631, United States

Location

BioSante Site 116

Mayfield Heights, Ohio, 44124, United States

Location

BioSante Site 138

West Chester, Ohio, 45069, United States

Location

BioSante Site 129

Tulsa, Oklahoma, 74104, United States

Location

BioSante Site #050

Eugene, Oregon, 97401, United States

Location

BioSante Site #106

Eugene, Oregon, 97401, United States

Location

BioSante Site 126

Medford, Oregon, 97504, United States

Location

BioSante Site #203

Portland, Oregon, 97227, United States

Location

BioSante Site 165

Jenkintown, Pennsylvania, 19046, United States

Location

BioSante Site 142

Pittsburgh, Pennsylvania, 15206, United States

Location

BioSante Site 099

Sellersville, Pennsylvania, 18960, United States

Location

BioSante Site 074

West Reading, Pennsylvania, 19611, United States

Location

BioSante Site 075

Warwick, Rhode Island, 02886, United States

Location

BioSante Site 117

Anderson, South Carolina, 29621, United States

Location

BioSante Site 089

Columbia, South Carolina, 29201, United States

Location

BioSante Site #209

Greer, South Carolina, 29651, United States

Location

BioSante Site 097

Hilton Head Island, South Carolina, 29926, United States

Location

BioSante Site 038

Mt. Pleasant, South Carolina, 29464, United States

Location

BioSante Site 093

Bristol, Tennessee, 37620, United States

Location

BioSante Site 069

Chattanooga, Tennessee, 37404, United States

Location

BioSante Site 002

Germantown, Tennessee, 38139, United States

Location

BioSante Site 078

Memphis, Tennessee, 38120, United States

Location

BioSante Site 042

Nashville, Tennessee, 37203, United States

Location

BioSante Site 048

Austin, Texas, 78705, United States

Location

BioSante Site 073

Corpus Christi, Texas, 78414, United States

Location

BioSante Site #220

Dallas, Texas, 75231, United States

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BioSante Site 147

Dallas, Texas, 75234, United States

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BioSante Site 039

Houston, Texas, 77054, United States

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BioSante Site 122

Houston, Texas, 77054, United States

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BioSante Site 154

Hurst, Texas, 76054, United States

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BioSante Site #211

San Antonio, Texas, 73229, United States

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BioSante Site 084

San Antonio, Texas, 78229, United States

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BioSante Site #218

Murray, Utah, 84123, United States

Location

BioSante Site 102

Salt Lake City, Utah, 84117, United States

Location

BioSante Site 168

Sandy City, Utah, 84070, United States

Location

BioSante Site 096

Williston, Vermont, 05495, United States

Location

BioSante Site 003

Charlottesville, Virginia, 22903, United States

Location

BioSante Site 086

Norfolk, Virginia, 23502, United States

Location

BioSante Site 053

Richmond, Virginia, 23294, United States

Location

BioSante Site 090

Virginia Beach, Virginia, 23456, United States

Location

BioSante Site #083

Mountlake Terrace, Washington, 98043, United States

Location

BioSante Site 128

Seattle, Washington, 98105, United States

Location

BioSante Site #158

Milwaukee, Wisconsin, 53209, United States

Location

BioSante Site #175

Vancouver, British Columbia, V5Z 4E1, Canada

Location

BioSante Site #164

Winnipeg, Manitoba, R3A 1M3, Canada

Location

BioSante Site 190

Hamilton, Ontario, L8M 1K7, Canada

Location

BioSante Site #088

Newmarket, Ontario, L3Y 5G8, Canada

Location

BioSante Site 088

Newmarket, Ontario, L3Y 5G8, Canada

Location

BioSante Site 188

Sarnia, Ontario, N7T 4X3, Canada

Location

BioSante Site 054

Windsor, Ontario, N8W 5L7, Canada

Location

BioSante Site 109

Québec, Quebec, G1S 2L6, Canada

Location

Related Publications (1)

• White WB, Grady D, Giudice LC, Berry SM, Zborowski J, Snabes MC. A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder. Am Heart J. 2012 Jan;163(1):27-32. doi: 10.1016/j.ahj.2011.09.021. Epub 2011 Nov 21.

  PMID: 22172433 DERIVED

Related Links

• www.Bloom study.com Click here for more information about this study: Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Breast Neoplasms

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Michael C Snabes, MD, PhD

  BioSante Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 12, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (141); CA (8)