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

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

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)


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

Inclusion Criteria:

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

  Show 30 Study Locations
Sponsors and Collaborators
Clarus Therapeutics, Inc.
Principal Investigator: Ronald Swerdloff, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Clarus Therapeutics, Inc. 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:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents processed this record on April 16, 2014