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

Information source: Clarus Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Male Hypogonadism

Intervention: oral testosterone undecanoate (Drug); topical testosterone gel 1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Clarus Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Ronald Swerdloff, MD, Principal Investigator, Affiliation: Los Angeles Biomedical Research Institute


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.

Clinical Details

Official title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of oral TU treated patients with average serum testosterone (T)concentrations (Cavg) between 300 and 1000 ng/dL.

Secondary outcome:

Comparison of change from baseline in safety parameters between treatment groups.

Percentage of treated patients with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng;dL, (b) between 1500 and 1800 ng/dl, (c) between 1800 and 2500 ng/dL, and (d) greater than 2500 ng/dL.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.


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.

Locations and Contacts

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

Additional Information

Starting date: July 2011
Last updated: December 17, 2013

Page last updated: August 23, 2015

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