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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01699178
Recruitment Status : Unknown
Verified December 2013 by Clarus Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2012
Last Update Posted : December 18, 2013
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Study Start Date : August 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

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
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Successful completion of CLAR-09007

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01699178

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

Responsible Party: Clarus Therapeutics, Inc. Identifier: NCT01699178     History of Changes
Other Study ID Numbers: CLAR-12010
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents