NCT06385509

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Tolmar Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Jatenzo	237 mg JATENZO twice daily

Timeline

• Start date: 2024-05-10
• Primary completion: 2025-11-01
• Completion: 2026-03-01
• First posted: 2024-04-26
• Last updated: 2025-09-04

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study