Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

NCT01235754 | Completed Phase 3

• 1 other identifier: TESTW009
• Study Type: interventional
• Target: 626
• Locations: 2 countries
• Sites: 102

Brief Summary

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

testosterone; hypoactive sexual desire disorder; menopause

Outcome Measures

Primary Outcomes (1)

• Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study

  This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

  12 weeks

Secondary Outcomes (2)

• change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study

  12 weeks

• change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study

  12 weeks

Study Arms (2)

placebo gel

PLACEBO COMPARATOR

placebo transdermal gel

Drug: placebo gel

testosterone gel

EXPERIMENTAL

transdermal testosterone gel

Drug: transdermal testosterone gel 1%

Interventions

transdermal testosterone gel 1% DRUG

300 mcg once daily transdermal testosterone gel 1%

Also known as: LibiGel transdermal testosterone gel 1%

testosterone gel

placebo gel DRUG

once daily transdermal placebo gel

Also known as: transdermal placebo gel

placebo gel

Eligibility Criteria

• Age: 30 Years - 66 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

You may not qualify if:

• Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator

Sponsors & Collaborators

• BioSante Pharmaceuticals: lead

Study Sites (102)

BioSante Site #095

Hoover, Alabama, 35216, United States

Location

BioSante Site #014

Huntsville, Alabama, 35801, United States

Location

BioSante Site #146

Mobile, Alabama, 36608, United States

Location

BioSante Site #171

Chandler, Arizona, 85224, 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 #052

Hot Springs, Arkansas, 71913, United States

Location

BioSante Site #155

Little Rock, Arkansas, 72223, United States

Location

BioSante Site #221

Berkeley, California, 94705, United States

Location

BioSante Site #182

Buena Park, California, 90620, United States

Location

BioSante Site #162

Sacramento, California, 95821, United States

Location

BioSante Site #008

San Diego, California, 92108, United States

Location

BioSante Site #159

Walnut Creek, California, 94598, United States

Location

BioSante Site #007

Denver, Colorado, 80218, United States

Location

BioSante Site #026

Lakewood, Colorado, 80239, 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 #143

Jacksonville, Florida, 32216, United States

Location

BioSante Site #024

Miami, Florida, 33126, United States

Location

BioSante Site #111

Orlando, Florida, 32806, 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 #115

Atlanta, Georgia, 30342, United States

Location

BioSante Site #141

Roswell, Georgia, 30075, United States

Location

BioSante Site #202

Idaho Falls, Idaho, 83404, United States

Location

BioSante Site #017

Meridian, Idaho, 83642, United States

Location

BioSante Site #189

Addison, Illinois, 60101, United States

Location

BioSante Site #133

Chicago, Illinois, 60654, United States

Location

BioSante Site #167

Newburgh, Indiana, 47630, United States

Location

BioSante Site #163

Overland Park, Kansas, 66202, United States

Location

BioSante Site #214

Lexington, Kentucky, 40504, United States

Location

BioSante Site #110

Metarie, Louisiana, 70006, United States

Location

BioSante Site #005

Shreveport, Louisiana, 71115, 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

Kalamazoo, Michigan, 49009, 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 #104

St Louis, Missouri, 63141, United States

Location

BioSante Site #127

Billings, Montana, 49101, United States

Location

BioSante Site #051

Missoula, Montana, 59808, United States

Location

BioSante Site #006

Lincoln, Nebraska, 68510, 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 #107

Raleigh, North Carolina, 27612, 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 #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 #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 #165

Jenkintown, Pennsylvania, 19046, United States

Location

BioSante Site #099

Sellersville, Pennsylvania, 18960, United States

Location

BioSante Site #197

Wexford, Pennsylvania, 15090, 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 #049

Watertown, South Dakota, 57201, United States

Location

BioSante Site #069

Chattanooga, Tennessee, 87404, United States

Location

BioSante Site #078

Memphis, Tennessee, 38120, United States

Location

BioSante Site #042

Nashville, Tennessee, 37203, United States

Location

BioSante Site #120

North Jackson, Tennessee, 38305, 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

Location

BioSante Site #147

Dallas, Texas, 75234, United States

Location

BioSante Site #039

Houston, Texas, 77054, United States

Location

BioSante Site #122

Houston, Texas, 77054, United States

Location

BioSante Site #154

Hurst, Texas, 76054, United States

Location

BioSante Site #211

San Antonio, Texas, 78229, United States

Location

BioSante Site #218

Murray, Utah, 84123, United States

Location

BioSante Site #144

Pleasant Grove, Utah, 84062, United States

Location

BioSante Site #102

Salt Lake City, Utah, 84117, 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 #083

Mountlake Terrace, Washington, 98043, United States

Location

BioSante Site #128

Seattle, Washington, 98105, United States

Location

BioSante Site #181

Tacoma, Washington, 98405, United States

Location

BioSante Site #183

Walla Walla, Washington, 99362, United States

Location

BioSante Site# 123

Ottawa, Ontario, K1H 7W9, Canada

Location

BioSante Site #188

Sarnia, Ontario, N7T 4X3, Canada

Location

BioSante Site #054

Windsor, Ontario, N8W 5L7, Canada

Location

BioSante Site #193

Shawinigan, Quebec, G9N 2H6, Canada

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Michael C Snabes, MD, PhD

  BioSante Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (98); CA (4)