Testosterone
The Role of Testosterone
The crucial role that testosterone plays in the human body has been neglected for far too long, with patients bearing the consequences.
Testosterone is essential to many bodily functions…
Neurological
Testosterone may play an important role in brain health and cognitive function, with low levels causing issues with memory, clarity and concentration. Mood disorders like anxiety and depression can be exacerbated by low testosterone.
Cardiovascular
Many studies have shown that testosterone is actually cardioprotective and is key in regulating blood flow, inflammation and vascular function.
Musculoskeletal
Testosterone is key in stimulating muscle tissue growth, increasing bone density and, by controlling metabolic efficiency, testosterone indirectly decreases body fat and glucose concentrations.
Urological
The hormone serves a meaningful role in sex drive and performance. When levels are too low, individuals experience low libido and erectile dysfunction.
The Men’s Health Crisis
Men Vs. Women 2021 Life Expectancy1
The mortality rate of men is higher than women in all stages of life.1
Men
73.2 Years
Women
79.1 Years
Low Testosterone Affects an Estimated 20 Million Men Aged 25-75 in the U.S2
Men born in recent years have lower testosterone levels than previous generations, with average levels declining by about 1% per year since 1984.3
Low T Comorbities
36.5% of men with
type 2 diabetes have low T4
50% of men who
are overweight have low T5
67% of men suffering
from erectile dysfunction
have low T6
Low Testosterone Affects an Estimated 20 Million Men Aged 25-75 in the U.S2
Low T can be a cause of osteoporosis in older men8
Positive Effects of Adequate Testosterone Levels
Better Metabolic Health
Improved Cardiovascular Function
Maintains Muscle Mass and Bone Density
Improved Cognitive Function
Decreased Inflammation
Lower Cholesterol
The Safety of Testosterone Replacement Therapy
Insights from the TRAVERSE Study
Cardiovascular Health and TRT
Study Participants
- The TRAVERSE study enrolled 5,246 men aged 45 to 80 with documented low testosterone and pre-existing or a high risk of cardiovascular disease.
- Patients with preexisting cardiovascular disease: 2,847
- Patients at elevated cardiovascular risk: 2,357
Findings from the TRAVERSE Study
TRT did not increase the risk of major heart problems compared to a non-treatment placebo.9
Cardiovascular Health and TRT
Study Participants
- The TRAVERSE study enrolled 5,246 men aged 45 to 80 with documented low testosterone and pre-existing or a high risk of cardiovascular disease.
- Patients with preexisting cardiovascular disease: 2,847
- Patients at elevated cardiovascular risk: 2,357
Findings from the TRAVERSE Study
TRT did not increase the risk of major heart problems compared to a non-treatment placebo.9
Insights from the T4DM Study: Using Testosterone to Prevent Type 2 Diabetes.
Men who received testosterone injections were less likely to develop type 2 diabetes.11
Low T can be a cause of osteoporosis in older men8
- Improvements in body weight, waist size and body mass index (BMI)11
- Lower fasting blood sugar levels and improved overall blood sugar control11
- Improved cholesterol levels and reduced blood pressure11
The Myth of Bioidentical Hormones
According to the FDA and several medical specialty groups, bioidentical hormones aren’t safer or more effective than hormones used in traditional hormone therapy.
Regulatory Oversight and Approval
Bioidentical hormones lack FDA regulation, leading to potential inconsistencies in dosage and safety.
Compounded Variability
Bioidentical hormones are often custom-compounded per prescription without standardized efficacy tests, raising reliability concerns.
Safety and Efficacy Claims
Claims of bioidentical hormones being safer and more effective than traditional therapies are not supported by substantial evidence.
Quality Concerns
Variability in quality and potency of bioidentical hormones poses safety risks; purity and composition are not guaranteed.
Clinical Perspective
Research does not support bioidentical hormones as superior to conventional hormone therapies.
Our Role in Driving Testosterone Research Forward
Ongoing Research
Through innovative clinical studies and collaborations with leading experts, we’re uncovering new insights into how testosterone impacts overall health and longevity.
Evidence-based Therapies
We ensure our therapies are backed by rigorous research, delivering effective, safe, and accessible treatment options for those with low testosterone.
Future Focus
As we continue to push boundaries, we’re focused on developing cutting-edge solutions that improve health outcomes and enhance quality of life for millions of people.
Marius Pharmaceuticals is shaping the future of hormone health — one breakthrough at a time.
References:
- Parker-Pope T, Gilbert C. A silent crisis in men’s health gets worse. Washington Post. April 17, 2023. Accessed June 5, 2024. https://www.washingtonpost.com/wellness/2023/04/17/mens-health-longevity-gap/
- Peterson MD, Belakovskiy A, McGrath R, Yarrow JF. Testosterone deficiency, weakness, and multimorbidity in men. Sci Rep. 2018;8(1):5897. doi:10.1038/s41598-018-24347-6
- Travison TG et al. A Population-Level Decline in Serum Testosterone Levels in American Men. J Clin Endocrinol Metab. Jan 2007. 92(1):196-202. https://doi.org/10.1210/jc.2006-1375. Accessed 2 Feb. 2024.
- Al Hayek AA, Khader YS, Jafal S, et al. Prevalence of low testosterone levels in men with type 2 diabetes mellitus: a cross-sectional study. J Family Community Med. 2013;20(3):179-186. doi:10.4103/2230-8229.122006
- Mulligan T, Frick MF, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. doi: 10.1111/j.1742-1241.2006.00992.x.
- Yassin AA, Saad F. Testosterone and erectile dysfunction. J Androl. 2008 Nov-Dec;29(6):593-604. doi: 10.2164/jandrol.107.004630.
- Shores MM, Sloan KL, Matsumoto AM, et al. Increased incidence of diagnosed depressive illness in hypogonadal older men. Arch Gen Psychiatry. 2004;61(2):162–167.
- Golds G, Houdek D, Arnason T. Male hypogonadism and osteoporosis: the effects, clinical consequences, and treatment of testosterone deficiency in bone health. Int J Endocrinol. 2017; 2017: 4602129. doi: 10.1155/2017/4602129
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023; 389:107-117. DOI: 10.1056/NEJMoa2215025
- Bhasin, S., Travison, T. G., Pencina, K. M., et al. (2023). Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(12):e2348692. doi:10.1001/jamanetworkopen.2023.48692
- Wittert G, Bracken K, Robledo KP, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes Endocrinol. 2021;9(1):32-45. doi:10.1016/S2213-8587(20)30367-3
Use
KYZATREX® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.
KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.
IMPORTANT SAFETY INFORMATION FOR KYZATREX®
KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.
- If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
- If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
- Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.
Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).
Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.
KYZATREX may cause other serious side effects including:
- Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
- If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
- Increased risk of prostate cancer.
- Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
- Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
- In large doses, KYZATREX may lower your sperm count.
- Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
- Swelling of your ankles, feet, or body (edema), with or without heart failure.
- Enlarged or painful breasts.
- Breathing problems while you sleep (sleep apnea).
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.
These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.
Keep KYZATREX and all medicines out of the reach of children.