Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
- Conditions
- Male Hypogonadism
- Interventions
- Registration Number
- NCT01699178
- Lead Sponsor
- Clarus Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an open-label study. This study contained an arm to evaluate the oral TU formulation as well as a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was included in the Phase III study and in this extension study to allow a general evaluation of comparative safety. Subjects randomized to oral TU in the Phase III study were continued on oral TU in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel therapy. This 2-year period of therapy and assessments was to provide a long-term view of the safety of oral TU and the stability of the T replacement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 182
- 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.)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral testosterone undecanoate Oral testosterone undecanoate Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months. Transdermal testosterone gel (AndroGel) Transdermal testosterone gel (AndroGel) Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in Prostate Volume Approximately 365 days Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in HDL Approximately 365 days Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in Hct Approximately 365 days Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in LDL Approximately 365 days Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in T Cholesterol Approximately 365 days Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Absolute Change From Baseline in Hgb Approximately 365 days Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Providence Clinical Research
🇺🇸Burbank, California, United States
Alabama Clinical Therapeutics, Inc.
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸Calera, Alabama, United States
Alabama Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc
🇺🇸Huntsville, Alabama, United States
Quality of Life Medical and Research Centers, LLC
🇺🇸Tucson, Arizona, United States
Tower Urology
🇺🇸Los Angeles, California, United States
South Orange County Endocrinology
🇺🇸Laguna Hills, 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
South Florida Medical Research
🇺🇸Aventura, Florida, United States
University of CT School of Medicine
🇺🇸New Haven, Connecticut, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Michael A. Werner
🇺🇸Purchase, New York, United States
University Urology Associates
🇺🇸New York, New York, United States
Bruce R. Gilbert, MD, PhD
🇺🇸Great Neck, New York, United States
Sunstone Medical Research
🇺🇸Medford, Oregon, United States
Urologic Consultants of Southeast Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Research Across America
🇺🇸Dallas, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Praxis Dr. Szymula
🇩🇪Leipzig, Germany
University of Bonn, Clinic for Dermatology and Allergy
🇩🇪Bonn, Germany
University of Halle, Center for Reproduction and Andrology
🇩🇪Halle, Germany
University of Muenster, Center for Reproduction and Andrology
🇩🇪Muenster, Germany
Praxis Dr. Schulze
🇩🇪Markkleeberg, Germany