Jatenzo for Low Testosterone
Recruiting at 27 trial locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Tolmar Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Men aged 18-65 with low testosterone, diagnosed as hypogonadal, can join this trial. They must not be on any testosterone treatments except the study drug and should have had at least one testosterone level below 300 ng/dL before the study. Participants need good vein access for blood samples and must follow the protocol.Inclusion Criteria
Subject must be able and willing to provide written informed consent and comply with the trial protocol and procedures
I have good vein access in my arm for treatments.
I am a man aged 18-65 with diagnosed low testosterone.
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Exclusion Criteria
Subject with a current or prior history of AI
Subject with specific cortisol levels or baseline CBG outside the reference range
Subject who received drugs as part of another research study within 30 days of initial dose administration
See 26 more
Treatment Details
Interventions
- JATENZO (Hormone Therapy)
Trial OverviewThe trial is testing JATENZO's effects on adrenal function in men with low testosterone over a period of 12 months. It's an open-label safety study, meaning everyone knows they're taking JATENZO and there are no placebos or comparison drugs involved.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: JATENZO® twice dailyExperimental Treatment1 Intervention
Participants receive 237 mg JATENZO twice daily, with the potential to be titrated to a higher or lower dose depending on serum testosterone levels.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tolmar Inc.
Lead Sponsor
Trials
5
Recruited
1,400+
ICON plc
Industry Sponsor
Trials
88
Recruited
28,900+
Dr. Steve Cutler
ICON plc
Chief Executive Officer since 2017
PhD from the University of Sydney, MBA from the University of Birmingham
Dr. Greg Licholai
ICON plc
Chief Medical Officer since 2023
Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College