The project aims to systematically investigate the serious side effects that can occur during cyproterone acetate (CPA) treatment. CPA is a synthetic hormone used to treat various conditions, including hirsutism, prostate cancer, polycystic ovary syndrome, paraphilias and gender dysphoria.
Although CPA has been in use for decades and is approved in many countries, there is currently no comprehensive, systematic overview of its potential risks and side effects. This project aims to address this issue.
The analysis will focus on serious adverse effects, such as liver damage, depressive disorders, and meningiomas. Only randomised controlled trials (RCTs) are evaluated to minimise bias due to study design. The results will highlight both common and previously undocumented or unpublished risks.
Methodologically, the project follows the JBI international system for systematic reviews and the PRISMA-P guidelines. A broad, multi-stage literature search of scientific databases and ‘grey literature’ will be conducted to identify as many relevant studies as possible, including unpublished studies and studies with incomplete reporting.
Significance of the project: The results of this review will provide a sound, evidence-based foundation for medical decisions, regulatory assessments, and patient education. This is particularly important where CPA is used off-label, for example in gender transition, and will contribute to greater transparency regarding benefit-risk considerations.
The project is being carried out by the JBI Centre for Gender Health Care under the direction of Dr Michelle Egloff. The team is supported by international experts in an open peer review process.