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

NCT00613002 | Completed Phase 3

• 1 other identifier: TESTW006
• Study Type: interventional
• Target: 597
• Locations: 2 countries
• Sites: 63

Brief 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

Conditions

Hypoactive Sexual Desire Disorder

Keywords

hypoactive sexual desire disorder; testosterone; menopause

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 21-24 weeks.

Secondary Outcomes (1)

• Change from baseline over time for multiple efficacy measurements

  change over timepoints from baseline

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

You may qualify if:

• Must be between the ages of 30 to 65 years
• Must have undergone hysterectomy and bilateral salpingo-oophorectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioSante Pharmaceuticals: lead

Study Sites (63)

BioSante Site #215

Birmingham, Alabama, 35209, United States

Location

BioSante Site #095

Hoover, Alabama, 35216, United States

Location

BioSante Site #014

Huntsville, Alabama, 35801, United States

Location

BioSante Site #027

Glendale, Arizona, 85308, United States

Location

BioSante Site #040

Tucson, Arizona, 85715, United States

Location

BioSante Site #052

Hot Springs, Arkansas, 71913, United States

Location

BioSante Site #182

Buena Park, California, 90620, United States

Location

BioSante Site #008

San Diego, California, 92108, United States

Location

BioSante Site #007

Denver, Colorado, 80218, United States

Location

BioSante Site #216

Denver, Colorado, 80239, 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 #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 #009

West Palm Beach, Florida, 33409, United States

Location

BioSante Site #189

Addison, Illinois, 60101, United States

Location

BioSante Site #005

Shreveport, Louisiana, 71115, United States

Location

BioSante Site #004

Baltimore, Maryland, 21285, United States

Location

BioSante Site #044

Detroit, Michigan, 48201, United States

Location

BioSante Site #047

Grand Rapids, Michigan, 49503, 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 #051

Missoula, Montana, 59808, United States

Location

BioSante Site #006

Lincoln, Nebraska, 68501, United States

Location

BioSante Site #217

Las Vegas, Nevada, 89146, United States

Location

BioSante Site #015

Poughkeepsie, New York, 12601, United States

Location

BioSante Site #059

Cary, North Carolina, 27518, United States

Location

BioSante Site #079

Charlotte, North Carolina, 28209, United States

Location

BioSante Site #061

Winston-Salem, North Carolina, 27103, United States

Location

BioSante Site #056

Fargo, North Dakota, 58103, United States

Location

BioSante Site #210

Akron, Ohio, 44311, United States

Location

BioSante Site #212

Cincinnati, Ohio, 45249, United States

Location

BioSante Site #213

Columbus, Ohio, 43212, United States

Location

BioSante Site #050

Eugene, Oregon, 97401, United States

Location

BioSante Site #197

Wexford, Pennsylvania, 15090, 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 #049

Watertown, South Dakota, 57201, United States

Location

BioSante Site #093

Bristol, Tennessee, 37620, United States

Location

BioSante Site #069

Chattanooga, Tennessee, 37404, 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

BioSane Site #220

Dallas, Texas, 75231, United States

Location

BioSante Site #039

Houston, Texas, 77054, United States

Location

BioSante Site #211

San Antonio, Texas, 78229, United States

Location

BioSante Site #218

Murray, Utah, 84123, 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 #181

Tacoma, Washington, 98405, United States

Location

BioSante Site #188

Sarnia, Ontario, N7T 4X3, Canada

Location

BioSante Site #054

Windsor, Ontario, N8W5L7, Canada

Location

BioSante Site #193

Shawinigan, Quebec, G9N 2H6, Canada

Location

Related Links

• http://www.bloomstudy.com

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Mental Disorders

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 30, 2008
• First Posted: February 12, 2008
• Study Start: December 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

CA (3); US (60)