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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Start date: May 10, 2024 to Jul 2, 2024 Show 5 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Mar 2026 to Nov 25, 2025
    • Interventions modified
    • Enrollment target: 110 to 116
    • Eligibility criteria expanded, about 8 words
  2. Primary completion date: Oct 2025 to Nov 2025
    • Study completion date: Feb 2026 to Mar 2026
    v13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 28 to 27
    v12
  4. Re-verified, no change to tracked fieldsv11
  5. Study sites: 25 to 28v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 9 to 25v9
  2. Eligibility criteria expanded, about 32 wordsv8
  3. Study sites: 8 to 9v7
  4. Study sites: 7 to 8v6
  5. Study sites: 5 to 7v5
  6. Study sites: 3 to 5v4
  7. Study sites: 1 to 3v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2024 to May 10, 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tolmar Inc.
3 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT06385509
Lead Sponsor Tolmar Inc.
Collaborators: ICON plc
Conditions
(from sponsor)		 Hypogonadism
Related terms Hypogonadism
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov