Study S000818

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05586802
Acronym: KLIN-HEALTH
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: RECRUITING
Enrollment: 150
Start: 2023-03-21
Primary completion: 2027-04-30
Lead sponsor: Georgios Papadakis
Conditions: Klinefelter Syndrome
Interventions: DRUG:Anastrozole; DRUG:Semaglutide; DRUG:human chorionic gonadotropin; DRUG:Testosterone gel
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Design 1 : sperm retrieval rate at mTESE biopsy [mTESE biopsy 26 weeks after hormonal intervention]
Design 2 : change in insulin resistance index (HOMA-IR) [From baseline to week 26 of intervention]

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