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Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
Sponsor: Georgios Papadakis
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.
Official title: Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study
Key Details
Gender
MALE
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-03-21
Completion Date
2027-04-30
Last Updated
2026-05-11
Healthy Volunteers
No
Conditions
Interventions
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
Semaglutide
This will be an experimental treatment for 26 weeks in Group 2 Arm E
human chorionic gonadotropin
This will be an experimental treatment for 26 weeks in addition to anastrozole in Group 1 - Arm B
Testosterone gel
This will be an active comparator for 26 weeks in Group 2 - Arm C
Locations (1)
Service of Endocrinology, Diabetes & Metabolism
Lausanne, Switzerland