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

Phase 3 Completed 182 enrolled Clarus Therapeutics, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2012-08
Primary completion: 2014-04
Completion: 2014-04

Publications

Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Testosterone	Small molecule	2.5 g	Other
Comparator	Testosterone	Small molecule	10 g	Other
Subject	Testosterone Undecanoate	Small molecule	100 mg	Oral
Subject	Testosterone Undecanoate	Small molecule	300 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications