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

NCT ID: NCT00657501

Last Updated: 2013-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoactive Sexual Desire Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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testosterone gel

1% testosterone transdermal gel

Group Type EXPERIMENTAL

testosterone gel

Intervention Type DRUG

once daily transdermal gel, 300 mcg

Placebo gel

placebo transdermal gel

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

once daily transdermal placebo gel

Interventions

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testosterone gel

once daily transdermal gel, 300 mcg

Intervention Type DRUG

placebo gel

once daily transdermal placebo gel

Intervention Type DRUG

Other Intervention Names

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LibiGel

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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BioSante Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael C Snabes, MD, PhD

Role: STUDY_DIRECTOR

BioSante Pharmaceuticals, Inc.

Locations

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BioSante Site #162

Sacramento, California, United States

Site Status

BioSante Site #112

San Diego, California, United States

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BioSante Site #159

Walnut Creek, California, United States

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BioSante Site #026

Lakewood, Colorado, United States

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BioSante Site #166

Farmington, Connecticut, United States

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BioSante Site #146

Mobile, Alabama, United States

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BioSante Site #171

Chandler, Arizona, United States

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BioSante Site #145

Glendale, Arizona, United States

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BioSante Site #121

Phoenix, Arizona, United States

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BioSante Site #137

Tucson, Arizona, United States

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BioSante Site #100

Jonesboro, Arkansas, United States

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BioSante Site #155

Little Rock, Arkansas, United States

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BioSante Site #221

Berkely, California, United States

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BioSante Site #132

New Britain, Connecticut, United States

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BioSante Site #151

New London, Connecticut, United States

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BioSante Site #143

Jacksonville, Florida, United States

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BioSante Site #111

Orlando, Florida, United States

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BioSante Site #152

Tampa, Florida, United States

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BioSante Site #115

Atlanta, Georgia, United States

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BioSante Site #141

Roswell, Georgia, United States

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BioSante Site #202

Idaho Falls, Idaho, United States

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BioSante Site #017

Meridian, Idaho, United States

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BioSante Site #156

Champaign, Illinois, United States

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BioSante Site #045

Chicago, Illinois, United States

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BioSante Site #149

Chicago, Illinois, United States

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BioSante Site #133

Chicago, Illinois, United States

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BioSante Site #167

Newburgh, Indiana, United States

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BioSante Site #163

Overland Park, Kansas, United States

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BioSante Site #214

Lexington, Kentucky, United States

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BioSante Site #136

Lexington, Kentucky, United States

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BioSante Site #157

Mandeville, Louisiana, United States

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BioSante Site #110

Metarie, Louisiana, United States

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BioSante Site #035

Ann Arbor, Michigan, United States

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BioSante Site #124

Bingham Farms, Michigan, United States

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BioSante Site #105

Kalamazoo, Michigan, United States

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BioSante Site #104

St Louis, Missouri, United States

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BioSante Site #127

Billings, Montana, United States

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BioSante Site #114

Las Vegas, Nevada, United States

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BioSante Site #161

Purchase, New York, United States

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BioSante Site #107

Raleigh, North Carolina, United States

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BioSante Site #131

Winston-Salem, North Carolina, United States

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BioSante Site #130

Beachwood, Ohio, United States

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BioSante Site #101

Cleveland, Ohio, United States

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BioSante Site #160

Englewood, Ohio, United States

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BioSante Site #153

Gallipolis, Ohio, United States

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Site #170

Kettering, Ohio, United States

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BioSante Site #116

Mayfield Heights, Ohio, United States

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BioSante Site #138

West Chester, Ohio, United States

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BioSante Site #129

Tulsa, Oklahoma, United States

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BioSante Site #106

Eugene, Oregon, United States

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BioSante Site #126

Medford, Oregon, United States

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BioSante Site #203

Portland, Oregon, United States

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BioSante Site #165

Jenkintown, Pennsylvania, United States

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BioSante Site #142

Pittsburgh, Pennsylvania, United States

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BioSante Site #099

Sellersville, Pennsylvania, United States

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BioSante Site #075

Warwick, Rhode Island, United States

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BioSante Site #117

Anderson, South Carolina, United States

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BioSante Site #120

North Jackson, Tennessee, United States

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BioSante Site #147

Dallas, Texas, United States

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BioSante Site #122

Houston, Texas, United States

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BioSante Site #154

Hurst, Texas, United States

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BioSante Site #084

San Antonio, Texas, United States

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BioSante Site #144

Pleasant Grove, Utah, United States

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BioSante Site #102

Salt Lake City, Utah, United States

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BioSante Site #128

Seattle, Washington, United States

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BioSante Site #183

Walla Walla, Washington, United States

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BioSante Site #175

Vancouver, British Columbia, Canada

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BioSante Site #123

Ottawa, Ontario, Canada

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BioSante Site #109

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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Other Identifiers

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TESTW008

Identifier Type: -

Identifier Source: org_study_id

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