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

NCT ID: NCT00613002

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

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

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 testosterone 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 testosterone 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 topical 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 #215

Birmingham, Alabama, United States

Site Status

BioSante Site #095

Hoover, Alabama, United States

Site Status

BioSante Site #014

Huntsville, Alabama, United States

Site Status

BioSante Site #027

Glendale, Arizona, United States

Site Status

BioSante Site #040

Tucson, Arizona, United States

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BioSante Site #052

Hot Springs, Arkansas, United States

Site Status

BioSante Site #182

Buena Park, California, United States

Site Status

BioSante Site #008

San Diego, California, United States

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BioSante Site #007

Denver, Colorado, United States

Site Status

BioSante Site #216

Denver, Colorado, United States

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BioSante Site #036

Ridgefield, Connecticut, United States

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BioSante Site #013

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

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BioSante Site #024

Miami, Florida, United States

Site Status

BioSante Site #219

Pinellas Park, Florida, United States

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BioSante Site #041

St. Petersburg, Florida, United States

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BioSante Site #009

West Palm Beach, Florida, United States

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BioSante Site #189

Addison, Illinois, United States

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BioSante Site #005

Shreveport, Louisiana, United States

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BioSante Site #004

Baltimore, Maryland, United States

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BioSante Site #044

Detroit, Michigan, United States

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BioSante Site #047

Grand Rapids, Michigan, United States

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BioSante Site #033

Saginaw, Michigan, United States

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BioSante Site #031

Saint Clair Shores, Michigan, United States

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BioSante Site #208

Edina, Minnesota, United States

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BioSante Site #198

Saint Paul, Minnesota, United States

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BioSante Site #051

Missoula, Montana, United States

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BioSante Site #006

Lincoln, Nebraska, United States

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BioSante Site #217

Las Vegas, Nevada, United States

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BioSante Site #015

Poughkeepsie, New York, United States

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BioSante Site #059

Cary, North Carolina, United States

Site Status

BioSante Site #079

Charlotte, North Carolina, United States

Site Status

BioSante Site #061

Winston-Salem, North Carolina, United States

Site Status

BioSante Site #056

Fargo, North Dakota, United States

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BioSante Site #210

Akron, Ohio, United States

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BioSante Site #212

Cincinnati, Ohio, United States

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BioSante Site #213

Columbus, Ohio, United States

Site Status

BioSante Site #050

Eugene, Oregon, United States

Site Status

BioSante Site #197

Wexford, Pennsylvania, United States

Site Status

BioSante Site #089

Columbia, South Carolina, United States

Site Status

BioSante Site #209

Greer, South Carolina, United States

Site Status

BioSante Site #097

Hilton Head Island, South Carolina, United States

Site Status

BioSante Site #038

Mt. Pleasant, South Carolina, United States

Site Status

BioSante Site #049

Watertown, South Dakota, United States

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BioSante Site #093

Bristol, Tennessee, United States

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BioSante Site #069

Chattanooga, Tennessee, United States

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BioSante Site #078

Memphis, Tennessee, United States

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BioSante Site #042

Nashville, Tennessee, United States

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BioSante Site #048

Austin, Texas, United States

Site Status

BioSante Site #073

Corpus Christi, Texas, United States

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BioSane Site #220

Dallas, Texas, United States

Site Status

BioSante Site #039

Houston, Texas, United States

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BioSante Site #211

San Antonio, Texas, United States

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BioSante Site #218

Murray, Utah, United States

Site Status

BioSante Site #096

Williston, Vermont, United States

Site Status

BioSante Site #003

Charlottesville, Virginia, United States

Site Status

BioSante Site #086

Norfolk, Virginia, United States

Site Status

BioSante Site #053

Richmond, Virginia, United States

Site Status

BioSante Site #090

Virginia Beach, Virginia, United States

Site Status

BioSante Site #083

Mountlake Terrace, Washington, United States

Site Status

BioSante Site #181

Tacoma, Washington, United States

Site Status

BioSante Site #188

Sarnia, Ontario, Canada

Site Status

BioSante Site #054

Windsor, Ontario, Canada

Site Status

BioSante Site #193

Shawinigan, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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http://www.bloomstudy.com

http://www.bloomstudy.com

Other Identifiers

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TESTW006

Identifier Type: -

Identifier Source: org_study_id

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