drugset

drugset / Trial / NCT01403116

Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

NCT01403116 ↗

Phase 3 Completed 325 enrolled Clarus Therapeutics, Inc. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · collab PharmaNet · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Timeline

Start: 2011-07
Primary completion: 2013-09
Completion: 2013-09

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
Subject	Testosterone Undecanoate	Small molecule	100 mg	Oral
Subject	Testosterone Undecanoate	Small molecule	150 mg	Oral
Subject	Testosterone Undecanoate	Small molecule	200 mg	Oral
Subject	Testosterone Undecanoate	Small molecule	300 mg	Oral
Comparator	topical testosterone gel	Unknown	2.5 g	Topical
Comparator	topical testosterone gel	Unknown	5 g	Topical
Comparator	topical testosterone gel	Unknown	7.5 g	Topical
Comparator	topical testosterone gel	Unknown	10 g	Topical

Indications