The purpose of this study is to determine the safety and efficacy of an oral testosterone
undecanoate formulation for use as testosterone-replacement therapy in men with low
testosterone.
Inclusion Criteria:
- Serum testosterone of less than or equal to 300 ng/dL on two occasions within one
week (may wash out from previous oral, topical or buccal testosterone therapy)
Exclusion Criteria:
- Significant intercurrent disease of any type, in particular liver, kidney,
uncontrolled or poorly controlled heart disease, or psychiatric illness
- Recent history of stroke, not including transient ischemic attack
- Untreated, sever obstructive sleep apnea.
- Hematocrit <35% or >48
- Serum transaminases >2 times upper limit of normal, serum bilirubin > 2. 0 mg/dL and
serum creatinine > 2. 0 mgk/dL
- BMI > or equal to 36
- Stable doses of lipid-lowering medication for less than 3 months
- Stable doses of oral medication for diabetes for less than 2 months
- Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or
equal to 19 points.
- History of breast cancer
- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary
supplements that may increase serum testosterone within previous 4 weeks
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
- History of abuse of alcohol or any drug substance within the previous 2 years
- Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or
long-acting opioid analgesics
- Receipt of any drug as part of a research study within 30 days of initial dose
administration in this study.
- Blood donation within the 12 week period before the initial study dose.
University of Bonn, Clinic for Dermatology and Allergy, Bonn, Germany
University of Halle, Center for Reproduction and Androlgoy, Halle, Germany
Praxis Dr. Szymula, Leipzig, Germany
Praxis Dr. Schulze, Markkleeberg, Germany
University of Muenster, Center for Reproduction and Andrology, Muenster, Germany
Alabama Clinical Therapeutics, Inc., Birmingham, Alabama 35235, United States
Alabama Internal Medicine, PC, Birmingham, Alabama 35235, United States
Alabama Clinical Therapeutics, Calera, Alabama 35040, United States
Medical Affliated Research Center, Inc., Huntsville, Alabama 35801, United States
Quality of Life Medical and Research Centers, LLC, Tucson, Arizona 85712, United States
Providence Clinical Research, Burbank, California 91505, United States
South Orange County Endocrinology, Laguna Hills, California 92653, United States
David Geffen School of Medicine, Los Angeles, California 90095, United States
Tower Urology, Los Angeles, California 90048, United States
Harbor-UCLA Medical Center, LA Biomedical Research Institute, Torrance, California 90502, United States
Connecticut Clinical Research Center/ConnecTrials, Middlebury, Connecticut 06762, United States
University of CT School of Medicine, New Haven, Connecticut 06511, United States
South Florida Medical Research, Aventura, Florida 33180, United States
University of Louisville, Louisville, Kentucky 40202, United States
Johns Hopkins University, Baltimore, Maryland 21287, United States
Boston University School of Medicine, Boston, Massachusetts 02118, United States
Maimonides Medical Center, Brooklyn, New York 11235, United States
Bruce R. Gilbert, MD, PhD, Great Neck, New York 11021, United States
University Urology Associates, New York, New York 10016, United States
Michael A. Werner, MD, PC, Purchase, New York 10577, United States
Sunstone Medical Research, Medford, Oregon 97504, United States
Urologic Consultants of Southeast Pennsylvania, Bala Cynwyd, Pennsylvania 19004, United States
Research Across America, Carrollton, Texas 75010, United States
Research Across America, Dallas, Texas 75234, United States
University of Washington, Seattle, Washington 98195, United States
