Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385509
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-19
Brief Title:
A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO for 12 Months
Sponsor:
Tolmar Inc
Organization:
Tolmar Inc
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None