Testosterone undecanoate is an FDA-approved oral testosterone capsule
When your testosterone levels are “off”, you might be too. If symptoms like decreased libido, fatigue, and low mood sound familiar, you could be one of the millions of men dealing with low testosterone. Testosterone Replacement Therapy (TRT) is revolutionizing the way men stay healthy, fit, and vital as they age.
Recognize the changes in your body and take action for your health.
How Does KYZATREX® Work?
KYZATREX®, is an FDA-approved prescription oral testosterone replacement therapy. It offers a different approach to improving testosterone levels in adult men with low testosterone due to certain medical conditions.
KYZATREX® is designed for the modern lifestyle, encapsulating efficacy, an established safety profile, and hassle-free administration in a convenient oral capsule.
Testosterone is the male sex hormone that is made in the testicles. Testosterone hormone levels are important to normal male sexual development and functions.
During puberty (in the teen years), testosterone helps boys develop male features like body and facial hair, deeper voice, and muscle strength. Men need testosterone to make sperm. Testosterone levels generally decrease with age, so older men tend to have low blood testosterone levels.
Some men have low testosterone levels. This is called Testosterone Deficiency Syndrome (TD) or Low Testosterone (Low T). Deficiency means that the body does not have enough of a needed substance. Syndrome is a group of symptoms that, together, suggest a disease or health condition.
Approved in 2022, KYZATREX brings a novel approach to testosterone replacement therapy that’s distinguished from traditional methods.
KYZATREX is designed to mimic the body’s natural testosterone production rhythm, avoiding the “peaks” and “valleys” typically seen with injectable testosterone. This results in a more stable hormonal balance that closely aligns with natural testosterone cycles.
In clinical studies, KYZATREX has demonstrated significant effectiveness. A 6-month study showed that 88% of participants reached normal testosterone levels within the first 90 days, with this figure rising to 96% over the full course of the study. This level of efficacy underscores KYZATREX’s potential as a transformative option in hormone replacement therapy.
Whether you’ve heard it called low testosterone, testosterone deficiency (TD), or hypogonadism, your body may not be making enough or any testosterone. And you’re far from alone: There are an estimated 20 million American men who are testosterone deficient.
Testosterone Replacement Therapy is a treatment to replace the testosterone that’s been lost and get T levels back to a normal range.
TRT has traditionally consisted of testosterone patches, gels, pellets, and injections. KYZATREX is here to change that, with capsules formulated to be easily absorbed and bypass your liver. That means it works efficiently, without causing liver damage.
KYZATREX® is designed for the modern lifestyle, encapsulating efficacy, an established safety profile, and hassle-free administration in a convenient oral capsule.
Just two oral KYZATREX® doses a day with food make it a safe and convenient option:
Medically Supervised Rx Testosterone Replacement Therapy (TRT)
KYZATREX® (testosterone undecanoate) is an FDA-approved prescription oral soft gel for adult men who have low or no testosterone due to certain medical conditions (such as hypogonadism). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Improper use may affect bone growth in children. KYZATREX is not meant for use by women. This TRT Program includes FDA-approved prescription KYZATREX (testosterone undecanoate) capsules when medically appropriate, ongoing medical support for prescription renewals each month, dosage increase guidance, and lab work. TRT Rx Drug products require a blood diagnostic test and online consultation with a licensed healthcare provider who will determine if the medication is appropriate. Your clinician will make a treatment decision based on your medical history and overall health after the completion of a lab test and telehealth consultation. Prescription testosterone is a Schedule III controlled substance and requires medical monitoring for as long as you take the medication. Thoroughly review all warnings and essential safety information regarding prescription testosterone drugs. 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. See important safety information.
1See KYZATREX prescribing information.
2Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.
KYZATREX® is an FDA-approved, twice-daily oral capsule for testosterone replacement therapy in adult males with conditions associated with deficiency or absence of endogenous testosterone, also known as hypogonadism. It helps increase testosterone levels, addressing issues like reduced libido, fatigue, and muscle loss. Studies show small increases in systolic blood pressure, especially in those on antihypertensive therapy, with minimal changes in diastolic blood pressure and heart rate. Careful monitoring is recommended for patients with hypertension. Overall, KYZATREX® is effective for testosterone replacement with manageable impacts on blood pressure [1][2].
References:
[1] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX® on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension, 23(7), 1420–1430. https://doi.org/10.1111/jch.14297
[2] Why KYZATREX®| Safe to Use, Easy to Take, and Up to 96% Effective. (n.d.). KYZATREX®. Retrieved May 17, 2024, from https://www.kyzatrex.com/why-kyzatrex/
KYZATREX® is an oral testosterone replacement therapy. It is absorbed through the lymphatic system, avoiding the liver's initial breakdown, which helps maintain stable testosterone levels. Once in the body, KYZATREX® converts to active testosterone, which binds to receptors in muscles, bones, and other tissues, improving energy, sex drive, and muscle mass. Testosterone works by binding to androgen receptors, which then regulate genes involved in male health and development. This process supports muscle growth, bone density, and sexual function, making KYZATREX® effective in treating low testosterone levels [1][2][3][4][5][6].
References:
[1] Kim, Y., Lee, D., Jo, H., Go, C., Yang, J., Kang, D., & Kang, J. S. (2021). GV1001 interacts with androgen receptor to inhibit prostate cell proliferation in benign prostatic hyperplasia by regulating expression of molecules related to epithelial-mesenchymal transition. Aging, 13(3), 3202–3217. https://doi.org/10.18632/aging.202242
[2] Ayoub, R., Page, S. T., Swerdloff, R. S., Liu, P. Y., Amory, J. K., Leung, A., Hull, L., Blithe, D., Christy, A., Chao, J. H., Bremner, W. J., & Wang, C. (2016). Comparison of the single dose pharmacokinetics, pharmacodynamics, and safety of two novel oral formulations of dimethandrolone undecanoate (DMAU): a potential oral, male contraceptive. Andrology, 5(2), 278–285. https://doi.org/10.1111/andr.12303
[3] Thomas, P. (2019). Membrane Androgen Receptors Unrelated to Nuclear Steroid Receptors. Endocrinology, 160(4), 772–781. https://doi.org/10.1210/en.2018-00987
[4] White, W. B., Bernstein, J. S., Rittmaster, R., & Dhingra, O. (2021). Effects of the oral testosterone undecanoate KYZATREX®on ambulatory blood pressure in hypogonadal men. The Journal of Clinical Hypertension, 23(7), 1420–1430. https://doi.org/10.1111/jch.14297
[5] A. Michael Lincoff, Bhasin, S., Panagiotis Flevaris, Mitchell, L. M., Shehzad Basaria, Boden, W. E., Cunningham, G. R., Granger, C. B., Khera, M., Thompson, I. M., Wang, Q., Wolski, K., Davey, D., Vidyasagar Kalahasti, Khan, N., Miller, M. G., Snabes, M. C., Chan, A., Dubcenco, E., & Li, X. (2023). Cardiovascular Safety of Testosterone-Replacement Therapy. https://doi.org/10.1056/nejmoa2215025
[6] Why KYZATREX®| Safe to Use, Easy to Take, and Up to 96% Effective. (n.d.). KYZATREX®. Retrieved May 17, 2024, from https://www.kyzatrex.com/why-kyzatrex/
KYZATREX testosterone therapy can offer several benefits for individuals with testosterone deficiency. It can improve sexual function by enhancing libido and erectile function, and it can boost mood and emotional well-being by alleviating symptoms of depression, irritability, and fatigue. Benefits of TRT for men can also include an increase muscle mass and strength, improved bone density, and help with the prevention of osteoporosis. For individuals with type 2 diabetes, TRT can improve glycemic control and insulin sensitivity. Additionally, TRT may positively impact cardiovascular health, cognitive functions like memory and processing speed, and overall quality of life. However, TRT should be administered under medical supervision, with regular monitoring to ensure safety and manage potential risks such as increased red blood cell count and cardiovascular concerns[1][2][3][4][5].
See Important Safety Information here.
References:
[1] Renke, G., & Tostes, F. (2023). Cardiovascular Safety and Benefits of Testosterone Implant Therapy in Postmenopausal Women: Where Are We? Pharmaceuticals, 16(4), 619. https://doi.org/10.3390/ph16040619
[2] Lawton, J., & Amjad, M. (2023). Weighing the Benefits and Drawbacks of Testosterone Replacement Therapy. Sciential - McMaster Undergraduate Science Journal, 10. https://doi.org/10.15173/sciential.v1i10.3364
[3] Yeo, S., Holl, K., Peñaherrera, N., Wissinger, U., Anstee, K., & Wyn, R. (2021). Burden of Male Hypogonadism and Major Comorbidities, and the Clinical, Economic, and Humanistic Benefits of Testosterone Therapy: A Narrative Review. ClinicoEconomics and Outcomes Research, Volume 13, 31–38. https://doi.org/10.2147/ceor.s285434
[4] Kumari, K., Kumar, R., Memon, A., Kumari, B., Tehrim, M., Kumari, P., Shehryar, M., Islam, H., Islam, R., Khatri, M., Kumar, S., & Kumar, A. (2023). Treatment with Testosterone Therapy in Type 2 Diabetic Hypogonadal Adult Males: A Systematic Review and Meta-Analysis. Clinics and Practice, 13(2), 454–469. https://doi.org/10.3390/clinpract13020041
[5] Fatih Aktoz, Ali Can Gunes, & Cemal Tamer Erel. (2023). What is the Role of Testosterone Therapy in Postmenopausal Women? A SWOT Analysis. Clinical and Experimental Obstetrics & Gynecology, 50(8), 159–159. https://doi.org/10.31083/j.ceog5008159
KYZATREX testosterone therapy can be used to treat erectile dysfunction (ED), particularly in men with low testosterone levels (hypogonadism). Studies show that testosterone therapy can significantly improve ED symptoms in hypogonadal men, with 91.9% of young men with organic ED reporting improvement after therapy[1]. Combining testosterone therapy with PDE5 inhibitors, like sildenafil, has proven effective for men who do not respond to PDE5 inhibitors alone, restoring erectile function in 70% of diabetic participants[2]. Long-term testosterone therapy has shown benefits in improving erectile function in men with functional hypogonadism and obesity, with significant improvements noted over up to 13 years[5]. Testosterone therapy has also been effective in men with venous leakage, with some reporting significant improvement within 12-20 weeks of treatment[3]. Additionally, in men with type 2 diabetes and hypogonadism, long-acting testosterone undecanoate improved sexual function and quality of life, including better IIEF scores[4]. Regular monitoring and a tailored approach by healthcare providers are essential to maximize benefits and manage potential risks.
See Important Safety Information here.
References:
[1] Song, J., G Saffati, Naeem, T., Biles, B., Pierce, H., Lipshultz, L., & Khera, M. (2024). (160) Improving Symptoms in Young Men with Erectile Dysfunction: Testosterone Therapy with or Without PDE5 Inhibitors. ̃the œJournal of Sexual Medicine, 21(Supplement_1). https://doi.org/10.1093/jsxmed/qdae001.151
[2] Kalinchenko, S. Y., Kozlov, G. I., Gontcharov, N. P., & Katsiya, G. V. (2003). Oral testosterone undecanoate reverses erectile dysfunction associated with diabetes mellitus in patients failing on sildenafil citrate therapy alone. The Aging Male: The Official Journal of the International Society for the Study of the Aging Male, 6(2), 94–99. https://pubmed.ncbi.nlm.nih.gov/12898793/
[3] Yassin, A., Saad, F., & Traish, A. M. (2006). Testosterone Undecanoate Restores Erectile Function in a Subset of Patients with Venous Leakage: A Series of Case Reports. The Journal of Sexual Medicine, 3(4), 727–735. https://doi.org/10.1111/j.1743-6109.2006.00267.x
[4] Hackett, G., Cole, N., Bhartia, M., Kennedy, D., Raju, J., & Wilkinson, P. (2013). Testosterone Replacement Therapy with Long‒Acting Testosterone Undecanoate Improves Sexual Function and Quality‒of‒Life Parameters vs. Placebo in a Population of Men with Type 2 Diabetes. The Journal of Sexual Medicine, 10(6), 1612–1627. https://doi.org/10.1111/jsm.12146
[5] Saad, F., Haider, K. S., Haider, A., Doros, G., & A Traish. (2023). (396) Effects of Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity on Weight, Waist Circumference, and Erectile Function – Results from a Registry Study. ̃the œ Journal of Sexual Medicine, 20(Supplement_1). https://doi.org/10.1093/jsxmed/qdad060.370
The KYZATREX® program is available in 49 States. The program is currently not available in New York. However, New Jersey, Rhode Island, and Connecticut are currently limited to at home labs only (walk-in labs are not an option).
Complete a brief questionnaire and we will determine if you qualify for this type of treatment. You will then be directed to get lab work completed. Once completed, you will meet with one of our providers virtually online who will then issue an Rx and forward your prescription to our pharmacy for fulfilment and shipping.
The initial cost for the KYZATREX program is $129. If approved for the program based on the medical provider's analysis of your blood results, the cost of medication is included in your first month of treatment. After the first month, there is a recurring cost of $219 which includes the cost of medication and any additional required lab tests (walk-ins) and provider visits.
KYZATREX is a cash-pay medication, removing the complications of insurance. Your doctor will provide you with instructions on how to fill your KYZATREX prescription. Experience the difference twice-daily KYZATREX can make in managing Low T.
Once approved to start treatment, your prescription is generated after the first consultation and sent to your address from one of our partnered pharmacies. The initial prescription includes a 30-day supply.
The initial payment will be authorized after checkout following your initial treatment protocol questionnaire.
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