Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
1 other identifier
interventional
182
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2012
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
October 30, 2018
CompletedJune 28, 2021
June 1, 2021
1.7 years
September 5, 2012
July 16, 2018
June 25, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
Absolute Change From Baseline in T Cholesterol
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.
Approximately 365 days
Absolute Change From Baseline in HDL
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.
Approximately 365 days
Absolute Change From Baseline in LDL
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.
Approximately 365 days
Absolute Change From Baseline in Hgb
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.
Approximately 365 days
Absolute Change From Baseline in Hct
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.
Approximately 365 days
Absolute Change From Baseline in Prostate Volume
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.
Approximately 365 days
Study Arms (2)
Oral testosterone undecanoate
EXPERIMENTALOral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
Transdermal testosterone gel (AndroGel)
ACTIVE COMPARATORTransdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
Interventions
Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
Eligibility Criteria
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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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 Affiliated 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
Tower Urology
Los Angeles, California, 90048, United States
David Geffen School of Medicine, UCLA
Los Angeles, California, 90095, 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
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
University of Bonn, Clinic for Dermatology and Allergy
Bonn, 53105, Germany
University of Halle, Center for Reproduction and Andrology
Halle, 06120, Germany
Praxis Dr. Szymula
Leipzig, 04105, Germany
Praxis Dr. Schulze
Markkleeberg, 04416, Germany
University of Muenster, Center for Reproduction and Andrology
Münster, 48149, Germany
Related Publications (1)
Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.
PMID: 36272969DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Theodore Danoff, MD, PhD
- Organization
- Clarus Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Swerdloff, MD
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2012
First Posted
October 3, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 28, 2021
Results First Posted
October 30, 2018
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
Individual Participant data shared with associated investigational sites only.