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Hormone Therapy

Jatenzo for Low Testosterone

Phase 4
Waitlist Available
Research Sponsored by Tolmar Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have adequate venous access in the left or right arm
Subject must be a man 18 to 65 years of age, with a prior clinical diagnosis of hypogonadism and at least one T level < 300 ng/dL prior to the study
Must not have
Subject currently receiving corticosteroids
Subject with a history of hypopituitarism or multiple endocrine deficiencies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is studying the safety of a medication called JATENZO on adrenal function in men with low testosterone levels who will be treated with JATENZO for 12 months.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects of JATENZO may include but are not limited to changes in blood pressure, mood swings, increased red blood cell count, liver function alterations, and potential impacts on cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have good vein access in my arm for treatments.
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I am a man aged 18-65 with diagnosed low testosterone.
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I have never used testosterone therapy or am willing to stop my current treatment.
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I agree to only use the study drug and no other testosterone treatments during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking corticosteroids.
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I have a history of issues with my pituitary gland or multiple hormone deficiencies.
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I have severe sleep apnea that hasn't been treated.
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I have a history of polycythemia.
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I am diabetic with high blood sugar levels over time.
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I have had a stroke, a transient ischemic attack, or a heart problem recently.
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I have high blood pressure.
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I have had recent heart issues or a stent placed.
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I have prostate issues indicated by tests or symptoms.
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I have a history of prostate or breast cancer.
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I am currently taking medication that affects testosterone levels or how it works in my body.
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I am not willing to stop taking biotin before tests.
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I am currently taking certain medications.
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I have a history of unusual bleeding or blood clots.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CST Test
Secondary study objectives
Adrenal Insufficiency
Other study objectives
Estrogen changes
Follicle Stimulating Hormone (FSH) changes.
Luteinizing hormone (LH) changes
+2 more

Side effects data

From 2023 Phase 4 trial • 41 Patients • NCT04983940
7%
Hypertension
2%
Chronic Kidney Disease
2%
Polycythemia
2%
Nocturia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Jatenzo Arm

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Jatenzo
2021
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

ICON plcIndustry Sponsor
85 Previous Clinical Trials
28,366 Total Patients Enrolled
Tolmar Inc.Lead Sponsor
4 Previous Clinical Trials
1,263 Total Patients Enrolled
~69 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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