Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
Recruiting
Phase 3
Interventional Study
Klinefelter Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 65
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Georgios Papadakis · Other
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About This Trial
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 …
Trial Locations
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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: …
Contacts