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

StatusActive, Not Recruiting
PhasePhase 4
Started2024-05-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 4, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 12 times since 2024-04-23; most recent filed 2025-09-02. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2025-09-02
Amendment Study Status v12
2024-10-18
Amendment RecruitingActive, Not Recruiting Study Status, Study Design, Contacts/Locations v11
2024-08-14
Amendment Study Status, Contacts/Locations v10
2024-08-07
Amendment Study Status, Contacts/Locations v9
2024-08-05
Amendment Study Status, Contacts/Locations v8
2024-07-22
Amendment Study Status, Outcome Measures, Eligibility v7
2024-06-13
Amendment Study Status, Contacts/Locations v6
2024-06-06
Amendment Study Status, Contacts/Locations v5
2024-05-31
Amendment Study Status, Contacts/Locations v4
2024-05-30
Amendment Study Status, Contacts/Locations v3
2024-05-23
Amendment Study Status, Contacts/Locations v2
2024-05-13
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v1
2024-04-23
Original filing
Trial Details
NCT Number NCT06385509
Lead Sponsor Tolmar Inc.
Collaborators: ICON plc
Conditions Hypogonadism
Enrollment 110 participants
Start Date 2024-05-10
Primary Completion 2025-11 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-09-04