Marius Pharmaceuticals, a company dedicated to developing therapies for testosterone deficiency, has launched a pilot study focusing on the effects of its oral testosterone therapy, KYZATREX (testosterone undecanoate), on male fertility, specifically spermatogenesis.

KYZATREX, approved for testosterone replacement therapy in adult males with testosterone deficiency, will be the subject of this pioneering study. The study aims to explore how this oral testosterone treatment impacts spermatogenesis, a crucial aspect of male fertility. This research is particularly significant as it examines the effects of an oral form of testosterone replacement therapy (TRT), whereas most existing data are based on traditional TRT methods like injections and patches.

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.”

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