NBN ISO 29943-1:2021

This document is intended to help in the design, execution, analysis and interpretation of clinical
function studies conducted in accordance with the requirements of ISO 23409 for male synthetic
condoms.
These clinical studies compare the performance of a new male condom to an established male condom
during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess
acute failure events during use (i.e. clinical slippage and clinical breakage).
This document also provides direction on the analysis of data when the study is completed, as well as
interpretation of these results by manufacturers and regulatory bodies.
Certain clinical trial elements are not addressed in this document, including compensation,
confidentiality of individuals and their records, use of local ethics committees, etc. These and many
other clinical trial design issues are covered in greater detail in ISO 14155.