Health TrialsbyHealthPanel

Testosterone Treatment in Men With Chronic Kidney Disease

ConditionsHypogonadism, MaleKidney Disease, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
SponsorSt. Louis University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)

Hematocrit >48% (as per Endocrine Society guidelines)(15)

Treatment with erythropoiesis stimulating agents (ESA)

Uncontrolled blood pressure (>180/100 mm Hg)

Trial design

Design model

Single group

Treatments tested in this trial

  • Jatenzo Pill

    Drug

    oral tablet daily

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Testosterone concentrations

Testosterone concentrations in serum measured multiple times during the study

Time frame
6 months

Secondary outcomes

1

Hemoglobin

blood test

Time frame
6 months
2

muscle strength

Hand-grip strength will be measured by a quantitative handgrip dynamometer in the dominant arm. Mean of three consecutive measurements will be used.

Time frame
6 months
3

Lean mass

measured by DEXA scan

Time frame
6 months
4

sexual function

Psychosexual daily questionnaire for 7 consecutive days will be used. The questionnaire covers three different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual desire (question 1) and sexual enjoyment (question 2) will be rated on a 7-point Likert-type scale from 0 to 7, with 0 indicating none and 7 indicating very high. Sexual performance will be assessed by % full erection and satisfaction with erection (questions 5 and 6). Sexual activity (question 4) will be assessed using a checklist format. The value will be recorded as 0 (none) or 1 (any) for analysis. Higher score indicates higher activity; maximum score on this item is 12. Each mood parameter (question 3) will also be assessed on the 7-point Likert scale.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Louis University

Lead sponsor

Clarus Therapeutics, Inc.

Collaborator

Source ClinicalTrials.gov
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