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Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

NCT05586802 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Georgios Papadakis

    lead OTHER

Principal Investigators

  • GEORGIOS PAPADAKIS, MD · Service of endocrinology, diabetes & metabolism, CHUV, Lausanne University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586802 on ClinicalTrials.gov