Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months

[madman]

ClinicalTrials.gov

clinicaltrials.gov

Study Overview

Brief Summary

TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months.


Detailed Description

Following all screening activities and confirmation that the subject has met all eligibility requirements, JATENZO treatment for approximately 1 year will begin. The dose of JATENZO will be titrated using its standard dose-titration algorithms based on serum testosterone levels. The Treatment Period will consist of Visits 1 - 12, with cosyntropin stimulation test completed at Visit 9 (Day 169 ±7) and Visit 12 (Day 365 ±7). At each visit during the Treatment Period, subjects will be evaluated for signs and symptoms of adrenal insufficiency, occurrence of adverse events, and changes in concomitant medications. There will be a safety follow-up visit 2 weeks after completion of Visit 12.

 

[Nelson Vergel]

Interesting. I wonder why they are doing this study. FDA post marketing study ?

 

[madman]

Interesting. I wonder why they are doing this study. FDA post marketing study ?

It would seem so.

Tolmar Pharmaceuticals, Inc. took over the rights to JATENZO® from Clarus Therapeutics Holdings, Inc. in 2022.

It's a Phase 4, multi-center, open-label safety study

They are also looking at oral TU effect on spermatogenesis.

Another study is also looking at oral TU effects on spermatogenesis in males.

Pilot Study Exploring the Effect of Its Oral T Therapy, KYZATREX®on Male Fertility

https://www.biospace.com/article/releases/marius-pharmaceuticals-announces-pilot-study-exploring-the-effect-of-its-oral-testosterone-therapy-kyzatrex-ciii-testosterone-undecanoate-capsules-on-male-fertility/?s=71

www.excelmale.com

*This study will be the first of its kind to specifically examine the effects of an oral TRT, like KYZATREX, on spermatogenesis