Authorised Therapeutic use (Phase IV) 47,XXY (Klinefelter syndrome)

Klinefelter syndrome – the effect of Testosterone treatment In PubertY A randomized, double-blind placebo-controlled intervention study ‘The TiPY study’

EU CTIS ID: 2023-505854-16-00

What this study is testing

The primary study objective is to evaluate the effect of two years testosterone replacement therapy (TRT) during puberty in boys with Klinefelter syndrome on changes in body composition

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • *Boys with Klinefelter syndrome (with a 47,XXY karyotype verified by conventional chromosome analysis or ArrayCGH). *Age 10-14 years at inclusion *LH > +2 standard deviations (SD) by ultrasensitive LH assay *Free T<+2SD *Signed consent from parents

You likely can't join if

  • *Previous or ongoing T treatment except for TRT because of micropenis during minipuberty *Contraindications to testosterone treatment *Participation in any other clinical trial

The study team makes the final eligibility decision.

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, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.