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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01699178
First received: September 5, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Male Hypogonadism
Drug: Oral testosterone undecanoate
Drug: Transdermal testosterone gel (AndroGel)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Resource links provided by NLM:


Further study details as provided by Clarus Therapeutics, Inc.:

Primary Outcome Measures:
  • Evidence of clinically significant safety related events in each treatment group [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Clinical laboratory, prostate volume, and cardiovascular biomarkers


Enrollment: 182
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of CLAR-09007
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699178

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

No publications provided

Responsible Party: Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01699178     History of Changes
Other Study ID Numbers: CLAR-12010
Study First Received: September 5, 2012
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 20, 2014