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New treatment option for Klinefelter Syndrome
Official title Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
ClinicalTrials.gov ID: NCT05586802
What this study is testing
What is Anastrozole?
Anastrozole is an investigational medicine, being studied as a potential treatment for klinefelter syndrome.
Also referred to as Anastrozole Teva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 65, men only
You may be able to join if
- -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
You likely can't join if
- 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)
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 16 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.