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

Condition(s) targeted: Hypoactive Sexual Desire Disorder

Intervention: transdermal testosterone gel 1% (Drug); placebo gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: BioSante Pharmaceuticals

Official(s) and/or principal investigator(s):
Michael C Snabes, MD, PhD, Study Director, Affiliation: BioSante Pharmaceuticals

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.

Official title: A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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

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

Minimum age: 30 Years. Maximum age: 66 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

clinical trial Exclusion Criteria:

- 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

BioSante Site #095, Hoover, Alabama 35216, United States

BioSante Site #014, Huntsville, Alabama 35801, United States

BioSante Site #146, Mobile, Alabama 36608, United States

BioSante Site #171, Chandler, Arizona 85224, United States

BioSante Site #027, Glendale, Arizona 85308, United States

BioSante Site #145, Glendale, Arizona 85306, United States

BioSante Site #121, Phoenix, Arizona 85015, United States

BioSante Site #137, Tucson, Arizona 85710, United States

BioSante Site #052, Hot Springs, Arkansas 71913, United States

BioSante Site #155, Little Rock, Arkansas 72223, United States

BioSante Site #221, Berkeley, California 94705, United States

BioSante Site #182, Buena Park, California 90620, United States

BioSante Site #162, Sacramento, California 95821, United States

BioSante Site #008, San Diego, California 92108, United States

BioSante Site #159, Walnut Creek, California 94598, United States

BioSante Site #007, Denver, Colorado 80218, United States

BioSante Site #026, Lakewood, Colorado 80239, United States

BioSante Site #132, New Britain, Connecticut 06050, United States

BioSante Site #151, New London, Connecticut 06320, United States

BioSante Site #036, Ridgefield, Connecticut 06877, United States

BioSante Site #143, Jacksonville, Florida 32216, United States

BioSante Site #024, Miami, Florida 33126, United States

BioSante Site #111, Orlando, Florida 32806, United States

BioSante Site #219, Pinellas Park, Florida 33781, United States

BioSante Site #041, St. Petersburg, Florida 33709, United States

BioSante Site #009, West Palm Beach, Florida 33409, United States

BioSante Site #115, Atlanta, Georgia 30342, United States

BioSante Site #141, Roswell, Georgia 30075, United States

BioSante Site #202, Idaho Falls, Idaho 83404, United States

BioSante Site #017, Meridian, Idaho 83642, United States

BioSante Site #189, Addison, Illinois 60101, United States

BioSante Site #133, Chicago, Illinois 60654, United States

BioSante Site #167, Newburgh, Indiana 47630, United States

BioSante Site #163, Overland Park, Kansas 66202, United States

BioSante Site #214, Lexington, Kentucky 40504, United States

BioSante Site #110, Metarie, Louisiana 70006, United States

BioSante Site #005, Shreveport, Louisiana 71115, United States

BioSante Site #206, Fall River, Massachusetts 02720, United States

BioSante Site #035, Ann Arbor, Michigan 48106, United States

BioSante Site #124, Bingham Farms, Michigan 48025, United States

BioSante Site #044, Detroit, Michigan 48201, United States

BioSante Site #047, Grand Rapids, Michigan 49503, United States

BioSante Site #105, Kalamazoo, Michigan 49009, United States

BioSante Site #033, Saginaw, Michigan 48604, United States

BioSante Site #031, St. Clair Shores, Michigan 48081, United States

BioSante Site #208, Edina, Minnesota 55435, United States

BioSante Site #198, St. Paul, Minnesota 55108, United States

BioSante Site #104, St. Louis, Missouri 63141, United States

BioSante Site #127, Billings, Montana 49101, United States

BioSante Site #051, Missoula, Montana 59808, United States

BioSante Site #006, Lincoln, Nebraska 68510, United States

BioSante Site #015, Poughkeepsie, New York 12601, United States

BioSante Site #059, Cary, North Carolina 27518, United States

BioSante Site #107, Raleigh, North Carolina 27612, United States

BioSante Site #131, Winston-Salem, North Carolina 27103, United States

BioSante Site #056, Fargo, North Dakota 58103, United States

BioSante Site #210, Akron, Ohio 44311, United States

BioSante Site #130, Beachwood, Ohio 44122, United States

BioSante Site #212, Cincinnati, Ohio 45249, United States

BioSante Site #101, Cleveland, Ohio 44122, United States

BioSante Site #213, Columbus, Ohio 43212, United States

BioSante Site #160, Englewood, Ohio 45322, United States

BioSante Site #153, Gallipolis, Ohio 45631, United States

BioSante Site #138, West Chester, Ohio 45069, United States

BioSante Site #129, Tulsa, Oklahoma 74104, United States

BioSante Site# 123, Ottawa, Ontario K1H 7W9, Canada

BioSante Site #188, Sarnia, Ontario N7T 4X3, Canada

BioSante Site #054, Windsor, Ontario N8W 5L7, Canada

BioSante Site #050, Eugene, Oregon 97401, United States

BioSante Site #106, Eugene, Oregon 97401, United States

BioSante Site #126, Medford, Oregon 97504, United States

BioSante Site #165, Jenkintown, Pennsylvania 19046, United States

BioSante Site #099, Sellersville, Pennsylvania 18960, United States

BioSante Site #197, Wexford, Pennsylvania 15090, United States

BioSante Site #193, Shawinigan, Quebec G9N 2H6, Canada

BioSante Site #117, Anderson, South Carolina 29621, United States

BioSante Site #089, Columbia, South Carolina 29201, United States

BioSante Site #209, Greer, South Carolina 29651, United States

BioSante Site #049, Watertown, South Dakota 57201, United States

BioSante Site #069, Chattanooga, Tennessee 87404, United States

BioSante Site #078, Memphis, Tennessee 38120, United States

BioSante Site #042, Nashville, Tennessee 37203, United States

BioSante Site #120, North Jackson, Tennessee 38305, United States

BioSante Site #048, Austin, Texas 78705, United States

BioSante Site #073, Corpus Christi, Texas 78414, United States

BioSante Site #147, Dallas, Texas 75234, United States

BioSante Site #220, Dallas, Texas 75231, United States

BioSante Site #039, Houston, Texas 77054, United States

BioSante Site #122, Houston, Texas 77054, United States

BioSante Site #154, Hurst, Texas 76054, United States

BioSante Site #211, San Antonio, Texas 78229, United States

BioSante Site #218, Murray, Utah 84123, United States

BioSante Site #144, Pleasant Grove, Utah 84062, United States

BioSante Site #102, Salt Lake City, Utah 84117, United States

BioSante Site #096, Williston, Vermont 05495, United States

BioSante Site #003, Charlottesville, Virginia 22903, United States

BioSante Site #086, Norfolk, Virginia 23502, United States

BioSante Site #053, Richmond, Virginia 23294, United States

BioSante Site #083, Mountlake Terrace, Washington 98043, United States

BioSante Site #128, Seattle, Washington 98105, United States

BioSante Site #181, Tacoma, Washington 98405, United States

BioSante Site #183, Walla Walla, Washington 99362, United States

Starting date: October 2010
Last updated: January 4, 2013