A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

• Status: Terminated
• Trial end date: 2018-05-03

Summary

This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to:

1. evaluate the dose-response curve following ascending single doses of TSX-011;

2. confirm optimum dosing conditions;

3. evaluate the efficacy of single or multiple daily adaptive dosing; and

4. evaluate the safety and tolerability of TSX-011.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: TesoRx Pharma, LLC
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate