NCT05586802 Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
| NCT ID | NCT05586802 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Georgios Papadakis |
| Condition | Klinefelter Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-03-21 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2023-03-21 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
GEORGIOS PAPADAKIS, MD
PRINCIPAL INVESTIGATOR
Service of endocrinology, diabetes & metabolism, CHUV, Lausanne University Hospital
Frequently Asked Questions
Who can join the NCT05586802 clinical trial?
This trial is open to male participants only, aged 16 Years or older, up to 65 Years, studying Klinefelter Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05586802 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT05586802 currently recruiting?
Yes, NCT05586802 is actively recruiting participants. Contact the research team at georgios.papadakis@chuv.ch for enrollment information.
Where is the NCT05586802 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05586802 clinical trial?
NCT05586802 is sponsored by Georgios Papadakis. The principal investigator is GEORGIOS PAPADAKIS, MD at Service of endocrinology, diabetes & metabolism, CHUV, Lausanne University Hospital. The trial plans to enroll 150 participants.