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RECRUITINGPhase 3NCT05586802

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

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...

Lead sponsor: Georgios Papadakis•1 locations•View source on ClinicalTrials.gov

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Contacts

GEORGIOS PAPADAKIS, MD

CONTACT

+41795560308 georgios.papadakis@chuv.ch

RIKIATOU FRANCIOLI, MD

CONTACT

+41795562861 Rikiatou.Francioli@chuv.ch

Sponsors

Lead Sponsor

Georgios Papadakis

Age

16 - 65 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Diagnosis of Klinefelter syndrome (47,XXY or mosaicism)
•Design 1:
•Age range: 16-40 years old
•Intention to become parent or interest in fertility preservation
•Confirmed azoospermia (lack of spermatozoids) after centrifugation of one semen sample
•Design 2:
•Age range: 18-65 years old
•No interest in fertility or fertility preservation
•Hypogonadism at diagnosis or after wash-out of testosterone replacement therapy
•High metabolic risk defined as overweight (BMI 25-28 kg/m2) and insulin resistance (HOMA-IR \> 2.6)

Exclusion Criteria

•Contraindications to testosterone-rising therapies (prostate or breast cancer, PSA \> 4 µg/l, active liver disease, symptomatic heart disease)
•Decreased life expectancy due to terminal disease
•Known or suspected non-compliance, drug or alcohol abuse
•Inability to follow the procedures of the study (language problems, severe psychological or mental disorders)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 5, 2024Terms

Trial snapshot

StatusRECRUITING

PhasePHASE3

Enrollment150

Start dateMar 2023

Last updatedJan 5, 2024

Condition

Klinefelter Syndrome

Locations shown

Service of Endocrinology, Diabetes & Metabolism

Lausanne

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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