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NCT06385509 · ClinicalTrials.gov registry record · Phase 4
A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months
A Phase 4 study of Hypogonadism, sponsored by Tolmar.
- Active
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT06385509: Active Phase 4 study of Hypogonadism, sponsored by Tolmar.
NCT06385509 is a Phase 4 study of Hypogonadism that is active but no longer recruiting, run by Tolmar. The registered enrollment target is 110 participants, roughly in line with the 115-participant average among 21 other Hypogonadism trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06385509, a Phase 4 study of Hypogonadism, is active but no longer recruiting, sponsored by Tolmar.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
To estimate the proportion of subjects with an abnormal post-stimulation cosyntropin stimulation test (CST) serum total cortisol level after approximately 6 and 12 months of treatment with JATENZO
Conditions Studied
Interventions
- DRUG Jatenzo
Study Locations (20)
Florida
- Hillcrest Medical Research, LLC - DeLand
- Global Health Clinical Trial Crop - Miami
- Reserka LLC - Miami
- Renstar Medical Research - Ocala
- Clinical Research Center of Florida - Pompano Beach
North Carolina
- Velocity Clinical Research, Inc. - Durham
- Catawba Valley Medical Group, Inc. - Hickory
- Raleigh Medical Group - Raleigh
- Piedmont Healthcare, PA - Statesville
- Wilmington Health, PLLC - Wilmington
California
- Clinical Trials Research - Lincoln
- Long Beach Research Institute, LLC - Long Beach
- Integrated Clinical Research - Tarzana
New York
- AccuMed Research Associates - Garden City
- Rochester Clinical Research, LLC - Rochester
Arizona
- Alliance for Multispecialty Research - Tempe
Georgia
- Velocity Clinical Research - Savannah
Maryland
- Centennial Medical Group - Columbia
Nebraska
- Velocity Clinical Research - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
What the registry record for NCT06385509 still lists
NCT06385509 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 21 other Hypogonadism trials with a reported enrollment target.
The record links to 1 condition, with Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which Jatenzo is the first listed.
NCT06385509 names 20 study sites across 9 states, led by Florida, North Carolina, California.
Frequently Asked Questions
What is clinical trial NCT06385509 about?
NCT06385509 is a clinical study titled "A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months". 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.
What is the current status of trial NCT06385509?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2024-05-10. Estimated completion is 2026-03.
What conditions does trial NCT06385509 study?
This clinical trial studies the following conditions: Hypogonadism.
What interventions are being tested in trial NCT06385509?
The interventions under investigation include: Jatenzo (DRUG).
Who is sponsoring clinical trial NCT06385509?
This trial is sponsored by Tolmar, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06385509 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypogonadism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06385509's enrollment target sits among peer trials
110 5th of 21 higher than 17 of 21 other Hypogonadism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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