Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announced it has initiated a pilot study to better understand the effect of oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate), on spermatogenesis in adult males.
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| [09-January-2024] |
| RALEIGH, N.C., Jan. 9, 2024 /PRNewswire/ -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announced it has initiated a pilot study to better understand the effect of oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate), on spermatogenesis in adult males. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
While it is generally accepted that TRT in males decreases spermatogenesis, which occurs through suppression of the hypothalamic-pituitary-gonadal axis, most data are derived from traditional routes of administration of TRT (e.g., injections, patches, gels, implantable pellets, etc.). This study will be the first of its kind to specifically examine the effects of an oral TRT, like KYZATREX, on spermatogenesis. Importantly, the American Urological Association currently recommends that physicians prescribing TRT inform their patients of the risks of the therapy on fertility. “We are eager to begin this new pilot study, as finding an option of TRT that does not reduce fertility in men would be a significant milestone in the field of andrology and society as a whole,” said Andrew Sun, M.D., Director at the Center for Men’s Health at Urology Partners of North Texas and Chief Medical Advisor for Marius Pharmaceuticals. “Too many men are suffering in silence from the effects of testosterone deficiency, and the results from this study could help us better understand the effects of oral TRT on spermatogenesis, which might potentially benefit a subset of men; those who are looking to start a family while still treating their low T.” Led by principal investigator Dr. Mohit Khera, Director of the Laboratory for Andrology Research Baylor College of Medicine, the study will enroll 20 male patients, ages 18-49 years old, who meet the American Urological Association’s criteria for hypogonadism and who have not previously used TRT. “Historically, testosterone products have been known to impair sperm production. Thus, many young hypogonadal men planning to achieve a pregnancy are unable to use testosterone due to an increased risk of suppressing their sperm production,” said Dr. Khera. “Identifying testosterone therapy that could potentially not suppress sperm production would be a significant advancement in the way we treat these hypogonadal men.” Participating patients will receive 200-400mg of KYZATREX BID for three months. Two semen analyses will be performed at baseline, one month, and three months, to assess any changes in each patient’s sperm count. Blood draws will also be taken at each of these timepoints to measure testosterone, hormones, lipids, and hematocrit. There will also be an additional blood draw two weeks after starting the therapy to support drug titration to reach therapeutic levels. Additionally, patients will receive the IIEF, PHQ-9, and SF36 questionnaires at baseline and at the conclusion of the study to assess symptoms of low testosterone. This pilot study is part of Marius Pharmaceuticals’ comprehensive effort to develop innovative therapies for testosterone deficiency. To learn more about KYZATREX, visit https://www.kyzatrex.com. To learn more about Marius Pharmaceuticals, visit https://www.mariuspharma.com. About KYZATREX® (testosterone undecanoate) KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius Pharmaceuticals Important Safety Information for KYZATREX® (testosterone undecanoate) Use Important Safety Information for KYZATREX® (testosterone undecanoate) 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.
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:
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 calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact:
SOURCE Marius Pharmaceuticals |
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