Pharma Fridays – January 12, 2024

An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *

Pilot Study Announced Exploring the Effect of Oral Testosterone Therapy (CIII testosterone undecanoate capsules) on Male Fertility

On January 9, Marius Pharmaceuticals, 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.

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. 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.

*Inclusion in Pharma Fridays does not suggest an endorsement by Endocrine News or the Endocrine Society.