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A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months

Hypogonadism Clinical Trial

Official title:
A Phase 4, Open-Label Study to Evaluate Primary Adrenal Function (Glucocorticoid Axis) in Hypogonadal Men Treated With JATENZO® for 12 Months

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06385509
Study type Interventional
Source Tolmar Inc.
Contact Jenn Pages
Phone 434-951-3432
Email jenn.pages@iconplc.com
Status Recruiting
Phase Phase 4
Start date May 10, 2024
Completion date February 2026
View Details
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