Safety and Efficacy Trial of Testosterone Undecanoate
- Registration Number
- NCT01765179
- Lead Sponsor
- Clarus Therapeutics, Inc.
- Brief Summary
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 144
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oral testosterone undecanoate Oral testosterone undecanoate -
- Primary Outcome Measures
Name Time Method Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114 The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
- Secondary Outcome Measures
Name Time Method Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114 The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Trial Locations
- Locations (25)
Medical Affliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
SC Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
South ORange County Endocrinology
🇺🇸Laguna Hill, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Jacksonville Impotence Treatment Center
🇺🇸Jacksonville, Florida, United States
Sunstone Medical Research
🇺🇸Medford, Oregon, United States
University Urology Associates
🇺🇸New York, New York, United States
Unrologic Consultants of SE Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Rainer Clinical Research Center, Inc.
🇺🇸Renton, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
LABiomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Tower Urology, Tower Research Institute
🇺🇸Los Angeles, California, United States
San Diego Sexual Medicine
🇺🇸San Diego, California, United States
Innovative Research of West Florida
🇺🇸Clearwater, Florida, United States
Research Across America
🇺🇸Dallas, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Alabama Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Precision Trials/Valley Urologic Associates
🇺🇸Phoenix, Arizona, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Potenium Clinical Research, LLC
🇺🇸Hurst, Texas, United States
Premier Clinical Research Center
🇺🇸Phoenix, Arizona, United States
Quality of LIfe Medical and Research Center
🇺🇸Tucson, Arizona, United States
Conneticut Clinical Research Center
🇺🇸Middlebury, Connecticut, United States