RecruitingPhase 2NCT05249634

Testosterone Treatment in Men With Chronic Kidney Disease

Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease


Sponsor

St. Louis University

Enrollment

20 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing testosterone replacement therapy in men with chronic kidney disease (CKD) who have low testosterone levels. Low testosterone is common in CKD and can cause fatigue, muscle loss, and sexual problems. Researchers want to see if replacing testosterone can improve these symptoms. **You may be eligible if...** - You are a man between 18 and 85 years old - You have moderate chronic kidney disease (eGFR between 15-45) - You have low testosterone levels (below 300 ng/dL) on two separate morning tests - You have symptoms of low testosterone such as low libido, fatigue, mood changes, or muscle loss - Your iron stores are normal **You may NOT be eligible if...** - You are currently on or have recently used testosterone therapy - Your red blood cell count is too high (hematocrit above 48%) - You are on erythropoiesis-stimulating drugs - You have uncontrolled high blood pressure or serious heart failure - You have had a heart attack, stroke, or heart surgery in the past 3 months - You have a history of prostate or breast cancer, or a high PSA level Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJatenzo Pill

oral tablet daily


Locations(1)

Saint Louis Univeristy

St Louis, Missouri, United States

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NCT05249634


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