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

madman

Super Moderator

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.



Screenshot (35882).png

Screenshot (35883).png

Screenshot (35880).png

1715895971113.webp
 

Attachments

  • Screenshot (35881).webp
    Screenshot (35881).webp
    107.7 KB · Views: 97
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.





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

Online statistics

Members online
0
Guests online
299
Total visitors
299

Latest posts

Back
Top