NCT05586802

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Georgios Papadakis · Academic / Other
• Sex: Male
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Klinefelter Syndrome

Interventions

Type	Name	Description
DRUG	Anastrozole	This will be an experimental treatment for 26 weeks in Group 1 Arm A and Arm B as well for Group 2 Arm D
DRUG	Semaglutide	This will be an experimental treatment for 26 weeks in Group 2 Arm E
DRUG	human chorionic gonadotropin	This will be an experimental treatment for 26 weeks in addition to anastrozole in Group 1 - Arm B
DRUG	Testosterone gel	This will be an active comparator for 26 weeks in Group 2 - Arm C

Timeline

• Start date: 2023-03-21
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-10-19
• Last updated: 2024-01-05

Locations

1 site across 1 country: Switzerland