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

Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

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.

Study Overview

• Status: Completed
• Conditions: Male Hypogonadism
• Intervention / Treatment: Drug: Oral testosterone undecanoate; Drug: Transdermal testosterone gel (AndroGel)

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53105
    • University of Bonn, Clinic for Dermatology and Allergy
  • Halle, Germany, 06120
    • University of Halle, Center for Reproduction and Andrology
  • Leipzig, Germany, 04105
    • Praxis Dr. Szymula
  • Markkleeberg, Germany, 04416
    • Praxis Dr. Schulze
  • Muenster, Germany, 48149
    • University of Muenster, Center for Reproduction and Andrology
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Internal Medicine, PC
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, Inc.
    • Calera, Alabama, United States, 35040
      • Alabama Clinical Therapeutics
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center, Inc
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical and Research Centers, LLC
  • California
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Laguna Hills, California, United States, 92653
      • South Orange County Endocrinology
    • Los Angeles, California, United States, 90048
      • Tower Urology
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine, UCLA
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center, LA Biomedical Research Institute
  • Connecticut
    • Middlebury, Connecticut, United States, 06762
      • Connecticut Clinical Research Center/ConnecTrials
    • New Haven, Connecticut, United States, 06511
      • University of CT School of Medicine
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine
  • New York
    • Brooklyn, New York, United States, 11235
      • Maimonides Medical Center
    • Great Neck, New York, United States, 11021
      • Bruce R. Gilbert, MD, PhD
    • New York, New York, United States, 10016
      • University Urology Associates
    • Purchase, New York, United States, 10577
      • Michael A. Werner
  • Oregon
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeast Pennsylvania
  • Texas
    • Carrollton, Texas, United States, 75010
      • Research Across America
    • Dallas, Texas, United States, 75234
      • Research Across America
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Subjects were to have completed Study CLAR-09007.
2. 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.
3. Subjects were required to remain off all forms of T except for study medication throughout the entire study.
4. 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:

1. 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.
2. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
3. 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.
4. Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA (serum PSA >4 ng/mL) at the final visit for Study CLAR-09007.
5. 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).
6. 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]).
7. Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
8. 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral testosterone undecanoate; Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.	Drug: Oral testosterone undecanoate; 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; Other Names: Oral TU
Active Comparator: Transdermal testosterone gel (AndroGel); Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months	Drug: Transdermal testosterone gel (AndroGel); Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD; Other Names: AndroGel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clarus Therapeutics, Inc.
• Investigators: Principal Investigator: Ronald Swerdloff, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: CLAR-12010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual Participant data shared with associated investigational sites only.