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

Hypogonadism Clinical Trial

Official title:
Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Clinical Trial 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.

Clinical Trial Description

Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters [testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00695110
Study type Interventional
Source Clarus Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date June 2008
Completion date August 2009
View Details
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