NCT03973840

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	Testosterone Undecanoate	dose was given orally and allowed to reach steady state

Timeline

• Start date: 2018-07-15
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2019-06-04
• Last updated: 2019-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study