Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Completed · Phase 3

Conditions studied: Male Hypogonadism

In brief

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.

Key facts

Study ID

NCT01403116

Run by

Clarus Therapeutics, Inc.

People needed

325

Starts

2011-07-01

Expected to finish

2013-09-01

Last updated by the study team

2018-08-14

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Alabama Clinical Therapeutics, Inc. — Birmingham, Alabama, United States
• Alabama Internal Medicine, PC — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics — Calera, Alabama, United States
• Medical Affliated Research Center, Inc. — Huntsville, Alabama, United States
• Quality of Life Medical and Research Centers, LLC — Tucson, Arizona, United States
• Providence Clinical Research — Burbank, California, United States
• South Orange County Endocrinology — Laguna Hills, California, United States
• Tower Urology — Los Angeles, California, United States
• David Geffen School of Medicine — Los Angeles, California, United States
• Harbor-UCLA Medical Center, LA Biomedical Research Institute — Torrance, California, United States
• Connecticut Clinical Research Center/ConnecTrials — Middlebury, Connecticut, United States
• University of CT School of Medicine — New Haven, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Bruce R. Gilbert, MD, PhD — Great Neck, New York, United States
• University Urology Associates — New York, New York, United States
• Michael A. Werner, MD, PC — Purchase, New York, United States
• Sunstone Medical Research — Medford, Oregon, United States
• Urologic Consultants of Southeast Pennsylvania — Bala-Cynwyd, Pennsylvania, United States
• Research Across America — Carrollton, Texas, United States
• Research Across America — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.