Phlebotomy Study of Testosterone Undecanoate

Status Completed

Clinical Trial Summary

An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Clinical Trial Description

This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation. ;

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT02670343
Study type	Interventional
Source	Clarus Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 2016
Completion date	March 2016

View Details

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