Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

Hypogonadism, Male Clinical Trial

Official title: A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes

Status Completed

Clinical Trial Summary

To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation

Clinical Trial Description

This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures [room temperature or on ice] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays. ;

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

• NCT number: NCT03973840
• Study type: Interventional
• Source: Clarus Therapeutics, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 15, 2018
• Completion date: July 31, 2018