Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

Completed · Phase 3

Conditions studied: Male Hypogonadism

In brief

The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.

Key facts

Study ID

NCT01699178

Run by

Clarus Therapeutics, Inc.

People needed

182

Starts

2012-08-01

Expected to finish

2014-04-01

Last updated by the study team

2021-06-28

Who can join

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

You may qualify if…

• Subjects were to have completed Study CLAR-09007.
• Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
• Subjects were required to remain off all forms of T except for study medication throughout the entire study.
• Subjects voluntarily gave written informed consent to participate in this study.
• Subjects meeting any of the following criteria were not eligible for participation in this study:
• Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness developed during the Phase III study that would, in the opinion of the Investigator, require exclusion from this study.
• Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
• Serum transaminases >2 times upper limit of normal (ULN), serum bilirubin >2.0 mg/dL and serum creatinine >2.0 mg/dL at the final visit for Study CLAR 09007.
• Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA (serum PSA >4 ng/mL) at the final visit for Study CLAR-09007.
• Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or dehydroepiandrosterone (DHEA).
• Known malabsorption syndrome and/or current treatment with oral lipase inhibitors (e.g., orlistat [Xenical]) and bile acid-binding resins (e.g., cholestyramine [Questran], colestipol [Colestid]).
• Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
• Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g., barbiturates, glucocorticoids [pharmacologic doses of glucocorticoids for replacement therapy were not exclusionary]) and potent CYP3A4 inhibitors (e.g., human immunodeficiency virus [HIV] antivirals [indinavir, nelfinavir, ritonavir, saquinavir, delaviridine], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note: Short-term ciprofloxacin administration completed more than 7 days prior to study visits was not exclusionary during the study.)

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 Affiliated 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, UCLA — 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 — 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

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