NCT02222558

Oral Testosterone for the Treatment of Hypogonadism in Males

A Phase 2B Study to Determine the Dose Response Pharmacokinetics of TSX-002 (Testosterone) in Hypogonadal Males

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: TesoRx Pharma, LLC · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

Detailed description

The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	TSX-002	TSX-002 are capsules with testosterone as the active ingredient.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2014-08-21
• Last updated: 2016-05-30
• Results posted: 2016-05-30

Locations

1 site across 1 country: United States