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Hormone Therapy

Jatenzo for Low Testosterone

Phase 4

Recruiting

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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CST Test

Secondary outcome measures

Adrenal Insufficiency

Other outcome measures

Estrogen changes

Follicle Stimulating Hormone (FSH) changes.

Luteinizing hormone (LH) changes

+2 more

Side effects data

From 2023 Phase 4 trial • 41 Patients • NCT04983940

Hypertension

Chronic Kidney Disease

Polycythemia

Nocturia

100%

80%

60%

40%

20%

Study treatment Arm

Jatenzo Arm

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

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

ICON plcIndustry Sponsor

84 Previous Clinical Trials

27,159 Total Patients Enrolled

Tolmar Inc.Lead Sponsor

4 Previous Clinical Trials

1,263 Total Patients Enrolled

~73 spots leftby Oct 2025

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