Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

What this study is testing ClinicalTrials.gov NCT05586802 ↗

Description as written by the study sponsor.

The study seeks primarily to determine whether modulation of systemic and testicular sex steroids balance by aromatase inhibitors will positively affect the metabolic health and spermatogenesis of men with Klinefelter syndrome (KFS) as compared to the current state of the art for each issue. Secondary objectives of this study are (i) to unravel the heterogeneity of the reproductive and metabolic phenotype of men with KFS by performing a multi-omic analysis in a large cohort at baseline; (ii) to evaluate the efficacy of semaglutide-induced weight loss to achieve metabolic and reproductive benefit in men with Klinefelter syndrome as compared to standard testosterone replacement; (ii) to assess whether addition of hCG to aromatase inhibitors further increases intratesticular testosterone and promotes spermatogenesis in men with KFS.

Treatments tested

• Anastrozole also known as Anastrozole Teva Drug

  This will be an experimental treatment for 26 weeks in Group 1 Arm A and Arm B as well for Group 2 Arm D

• Semaglutide also known as Ozempic Drug

  This will be an experimental treatment for 26 weeks in Group 2 Arm E

• human chorionic gonadotropin also known as Choriomon Drug

  This will be an experimental treatment for 26 weeks in addition to anastrozole in Group 1 - Arm B

• Testosterone gel also known as Tostran Drug

  This will be an active comparator for 26 weeks in Group 2 - Arm C