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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: October 1, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 325
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

  Show 30 Study Locations
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: October 1, 2012
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 June 18, 2013