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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05586802
Other study ID # PZ00P3_202151
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 21, 2023
Est. completion date April 1, 2026

Study information

Verified date December 2023
Source University of Lausanne Hospitals
Contact GEORGIOS PAPADAKIS, MD
Phone +41795560308
Email georgios.papadakis@chuv.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender Male
Age group 16 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Country Name City State
Switzerland Service of Endocrinology, Diabetes & Metabolism Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Georgios Papadakis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Design 1 : sperm retrieval rate at mTESE biopsy Sperm retrieval rate at mTESE biopsy (Group A and B) mTESE biopsy 26 weeks after hormonal intervention
Primary Design 2 : change in insulin resistance index (HOMA-IR) HOMA-IR calculated using fasting glucose and insulin levels From baseline to week 26 of intervention
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