Safety and Efficacy Trial of Testosterone Undecanoate

Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men

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

Study Overview

• Status: Completed
• Conditions: Male Hypogonadism
• Intervention / Treatment: Drug: Oral testosterone undecanoate

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Birmingham, Alabama, United States, 35235
      • Alabama Internal Medicine, PC
    • Huntsville, Alabama, United States, 35801
      • Medical Affliated Research Center, Inc.
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Precision Trials/Valley Urologic Associates
    • Phoenix, Arizona, United States, 85027
      • Premier Clinical Research Center
    • Phoenix, Arizona, United States, 85032
      • Precision Trials/Valley Urologic Associates
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical and Research Center
  • California
    • Garden Grove, California, United States, 92844
      • SC Clinical Research, Inc.
    • Laguna Hill, California, United States, 92653
      • South Orange County Endocrinology
    • Los Angeles, California, United States, 90048
      • Tower Urology, Tower Research Institute
    • San Diego, California, United States, 92120
      • San Diego Sexual Medicine
    • Torrance, California, United States, 90502
      • LABiomedical Research Institute at Harbor-UCLA Medical Center
  • Connecticut
    • Middlebury, Connecticut, United States, 06762
      • Conneticut Clinical Research Center
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • Jacksonville, Florida, United States, 32223
      • Jacksonville Impotence Treatment Center
  • New York
    • New York, New York, United States, 10016
      • University Urology Associates
  • Oregon
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Unrologic Consultants of SE Pennsylvania
  • Texas
    • Carrollton, Texas, United States, 75010
      • Research Across America
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Hurst, Texas, United States, 76053
      • Potenium Clinical Research, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Washington
    • Renton, Washington, United States, 98057
      • Rainer Clinical Research Center, Inc.
    • 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:

• 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)

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral testosterone undecanoate	Drug: Oral testosterone undecanoate; Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL	The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population	The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114

Collaborators and Investigators

• Sponsor: Clarus Therapeutics, Inc.
• Collaborators: inVentiv Health Clinical
• Investigators: Principal Investigator: Ronald Swerdloff, MD, Los Andgeles Biomedical Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: testosterone; male hypogonadism; low testosterone
• 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-12011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No