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

September 5, 2012
December 17, 2013
August 2012
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01699178 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Male Hypogonadism
  • Drug: Oral testosterone undecanoate
  • Drug: Transdermal testosterone gel (AndroGel)
  • Experimental: Oral testosterone undecanoate
    Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
    Intervention: 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
    Intervention: Drug: Transdermal testosterone gel (AndroGel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
182
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of CLAR-09007
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01699178
CLAR-12010
No
Clarus Therapeutics, Inc.
Clarus Therapeutics, Inc.
Not Provided
Principal Investigator: Ronald Swerdloff, MD University of California, Los Angeles
Clarus Therapeutics, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP