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New treatment option for Hypogonadism, Male
Official title Testosterone Treatment in Men With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05249634
What this study is testing
What is Jatenzo Pill?
Jatenzo Pill is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypogonadism, male.
Also referred to as oral testosterone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- 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...
- Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%.
You likely can't join if
- 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)
- Heart Failure, class III or IV
- Myocardial infarction, stroke, or heart surgery in the past 3 months
See the full eligibility 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...
- Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%.
- 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)
- Heart Failure, class III or IV
- Myocardial infarction, stroke, or heart surgery in the past 3 months
- Breast cancer
- History of prostate cancer
- Prostate specific antigen (PSA) \>4 ng/ml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)
- HIV or untreated hepatitis C
- Untreated, severe obstructive sleep apnea
- Initiated iron replacement in the last 3 months
- deep venous thrombosis or pulmonary embolism in the last 3 months
- recurrent (more than once) deep venous thrombosis or pulmonary embolism
- use of warfarin
- Planning to have children in the next one year
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.