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ACTIVE NOT RECRUITING Phase 4

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

NCT06385509 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 110 participants
Start Date 2024-05-10
Est. Completion 2026-03
Phase Phase 4

Sponsor

Tolmar

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06385509

The ClinicalTrials.gov registry entry for NCT06385509 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tolmar, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06385509 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, North Carolina, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06385509?

The interventions under investigation include: Jatenzo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06385509?

This trial is sponsored by Tolmar, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial