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drugset / Trial / NCT00695110

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

NCT00695110 ↗

Phase 2 Completed 29 enrolled Clarus Therapeutics, Inc. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

Timeline

Start: 2008-06
Primary completion: 2008-12
Completion: 2009-08

Publications

Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Testosterone Enanthate	Small molecule	200 mg	Oral
Subject	Testosterone Enanthate	Small molecule	300 mg	Oral
Subject	Testosterone Undecanoate	Small molecule	200 mg	Oral
Subject	Testosterone Undecanoate	Small molecule	300 mg	Oral

Indications