Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease
St. Louis University
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).
Description
* Purpose. The purpose of this research is to find out if JATENZO will help increase testosterone levels in men with hypogonadism and chronic kidney disease, determine if there is any improvement in testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass and sexual function. * The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also…
Eligibility
- Age range
- 18–85 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Men between ages of 18-85 years of age * eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation * Subnormal total serum T concentrations (\<300 ng/dl) on two separate occasions in morning * Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15) * Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation…
Interventions
- DrugJatenzo Pill
oral tablet daily
Location
- Saint Louis UniveristySt Louis, Missouri