Overview

This trial is active, not recruiting.

Condition male hypogonadism
Treatments oral testosterone undecanoate, transdermal testosterone gel (androgel)
Phase phase 4
Sponsor Clarus Therapeutics, Inc.
Start date August 2012
End date April 2014
Trial size 182 participants
Trial identifier NCT01699178, CLAR-12010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
oral testosterone undecanoate
(Active Comparator)
Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
transdermal testosterone gel (androgel)

Primary Outcomes

Measure
Evidence of clinically significant safety related events in each treatment group
time frame: 12 months

Eligibility Criteria

Male participants from 18 years up to 75 years old.

Inclusion Criteria: - Successful completion of CLAR-09007

Additional Information

Official title Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Principal investigator Ronald Swerdloff, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Clarus Therapeutics, Inc..