drugset / Trial / NCT05586802

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

NCT05586802

Phase 3 Recruiting 150 enrolled Georgios Papadakis
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-03-21
Primary completion
2027-04-30
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified
Subject Semaglutide Peptide
Comparator Testosterone gel Unknown
Subject human chorionic gonadotropin Protein / enzyme biologic

Indications