Safety and Efficacy Trial of Testosterone Undecanoate

Completed · Phase 3

Conditions studied: Male Hypogonadism

In brief

The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.

Key facts

Study ID

NCT01765179

Run by

Clarus Therapeutics, Inc.

People needed

144

Starts

2013-01-01

Expected to finish

2013-07-01

Last updated by the study team

2017-12-12

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 (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)

You may not qualify if…

• Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
• Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
• Untreated, severe 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 mg/dL
• BMI > or equal to 38
• Stable doses of lipid-lowering medication for less than three months
• Stable doses of oral medication for diabetes for less than two months
• Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate cancer.
• History of breast cancer
• Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
• Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
• Known history of abuse of alcohol or any drug substance with 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 initial dose administration in this study

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Alabama Internal Medicine, PC — Birmingham, Alabama, United States
• Medical Affliated Research Center, Inc. — Huntsville, Alabama, United States
• Precision Trials/Valley Urologic Associates — Glendale, Arizona, United States
• Premier Clinical Research Center — Phoenix, Arizona, United States
• Precision Trials/Valley Urologic Associates — Phoenix, Arizona, United States
• Quality of LIfe Medical and Research Center — Tucson, Arizona, United States
• SC Clinical Research, Inc. — Garden Grove, California, United States
• South ORange County Endocrinology — Laguna Hill, California, United States
• Tower Urology, Tower Research Institute — Los Angeles, California, United States
• San Diego Sexual Medicine — San Diego, California, United States
• LABiomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Conneticut Clinical Research Center — Middlebury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• PAB Clinical Research — Brandon, Florida, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• Jacksonville Impotence Treatment Center — Jacksonville, Florida, United States
• University Urology Associates — New York, New York, United States
• Sunstone Medical Research — Medford, Oregon, United States
• Unrologic Consultants of SE Pennsylvania — Bala-Cynwyd, Pennsylvania, United States
• Research Across America — Carrollton, Texas, United States
• Research Across America — Dallas, Texas, United States
• Clinical Trial Network — Houston, Texas, United States
• Potenium Clinical Research, LLC — Hurst, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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