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

Who is this study for? Men who have low testosterone and chronic kidney disease
What treatments are being studied? Jatenzo
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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 (TSAT) ≥20%.

Locations
United States
Missouri
Saint Louis Univeristy
RECRUITING
St Louis
Contact Information
Primary
Sandeep Dhindsa, MD
sandeep.dhindsa@health.slu.edu
314-977-9320
Backup
Jennifer Newman, RN
jennifer.newman@heath.slu.edu
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2028-12
Participants
Target number of participants: 20
Treatments
Experimental: treatment
JATENZO daily for 6 months
Sponsors
Leads: St. Louis University
Collaborators: Clarus Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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