ISO 29943-1:2017

Overview

ISO 29943-1:2017 - "Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports" provides guidance for designing, conducting, analysing and interpreting clinical function studies for male synthetic condoms. The standard supports clinical validation required by ISO 23409, focusing on acute performance during vaginal intercourse (not anal intercourse) and relying primarily on participant self-reports.

Key topics and technical requirements

• Primary objective: Compare a new (test) male condom to an established (control) condom for acute failure events - primarily clinical breakage and clinical slippage (complete slippage during intercourse or withdrawal).
• Study design elements covered: pilot studies, clinical validation investigation, enrolment and informed consent, randomization, allocation concealment and masking.
• Data capture and integrity: recommended formats and schedules for interviews, individual condom-use case report forms (CRFs), mid-study CRFs, use of IVRS, mail-in or web-based reporting and related data-quality measures.
• Material and supply controls: guidance on test and control condom selection, storage, expiration considerations and analysis of returned used condoms.
• Statistical considerations: guidance on defining outcome measures, power calculations, statistical analysis plans, and interpretation using non-inferiority and superiority frameworks. Annexes provide sample CRFs, schedules and a power formula.
• Safety reporting: direction for adverse event recording and interpretation.
• Limits: ISO 29943-1:2017 does not address broader clinical-trial operational issues such as compensation, confidentiality, local ethics committees or full human-subject protections - see ISO 14155 for those topics.

Practical applications and users

• Who uses it: condom manufacturers, clinical researchers, regulatory reviewers, quality and R&D teams, contract research organizations (CROs) and notified bodies assessing new synthetic male condom materials.
• Use cases:
  • Designing clinical function studies to support product registration and regulatory submissions.
  • Preparing statistical analysis plans and CRFs for multi-centre trials based on self-reported outcomes.
  • Interpreting trial results for non-inferiority versus established natural rubber latex controls.
  • Implementing data-collection workflows (web, IVRS, paper) and procedures for returned-condom analysis.

Related standards

• ISO 23409 - requirements for synthetic male condoms (normative context for clinical validation).
• ISO 4074:2015 - specifications for natural rubber latex condoms (referenced in background).
• ISO 14155 - Good clinical practice for medical device investigations (covers ethics, confidentiality and other trial elements not addressed here).

Keywords: ISO 29943-1:2017, male condoms, clinical function studies, self-reports, clinical breakage, clinical slippage, ISO 23409, non-inferiority, statistical analysis, condom manufacturers.