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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Clarus Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699178
First Posted: October 3, 2012
Last Update Posted: December 18, 2013
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.
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.
September 5, 2012
October 3, 2012
December 18, 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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
182
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of CLAR-09007
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
 
 
NCT01699178
CLAR-12010
No
Not Provided
Not Provided
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