325
Participants
Start Date
July 31, 2011
Primary Completion Date
September 30, 2013
Study Completion Date
September 30, 2013
Oral testosterone undecanoate
Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
topical testosterone gel
Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
University Urology Associates, New York
Michael A. Werner, MD, PC, Purchase
Bruce R. Gilbert, MD, PhD, Great Neck
Maimonides Medical Center, Brooklyn
Urologic Consultants of Southeast Pennsylvania, Bala-Cynwyd
Johns Hopkins University, Baltimore
South Florida Medical Research, Aventura
Alabama Clinical Therapeutics, Calera
Alabama Clinical Therapeutics, Inc., Birmingham
Alabama Internal Medicine, PC, Birmingham
Medical Affliated Research Center, Inc., Huntsville
University of Louisville, Louisville
Research Across America, Carrollton
Research Across America, Dallas
Quality of Life Medical and Research Centers, LLC, Tucson
Tower Urology, Los Angeles
David Geffen School of Medicine, Los Angeles
Harbor-UCLA Medical Center, LA Biomedical Research Institute, Torrance
Providence Clinical Research, Burbank
South Orange County Endocrinology, Laguna Hills
Sunstone Medical Research, Medford
University of Washington, Seattle
Connecticut Clinical Research Center/ConnecTrials, Middlebury
University of CT School of Medicine, New Haven
Boston University School of Medicine, Boston
University of Bonn, Clinic for Dermatology and Allergy, Bonn
University of Halle, Center for Reproduction and Androlgoy, Halle
Praxis Dr. Szymula, Leipzig
Praxis Dr. Schulze, Markkleeberg
University of Muenster, Center for Reproduction and Andrology, Münster
Lead Sponsor
Collaborators (1)
PharmaNet
INDUSTRY
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Clarus Therapeutics, Inc.
INDUSTRY