ISO 29943-1:2017

Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports

ISO 29943-1:2017 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). ISO 29943-1:2017 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.

Préservatifs — Directives relatives aux études cliniques — Partie 1: Préservatifs masculins — Études fonctionnelles cliniques basées sur des auto-déclarations

General Information

• Status: Published
• Publication Date: 05-Jul-2017
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
• Drafting Committee: ISO/TC 157/WG 20 - Clinical trials
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 08-Dec-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 29943-1
First edition
2017-07
Condoms — Guidance on clinical
studies —
Part 1:
Male condoms, clinical function
studies based on self-reports
Préservatifs — Directives relatives aux études cliniques —
Partie 1: Préservatifs masculins — Études fonctionnelles cliniques
basées sur des auto-déclarations
Reference number
ISO 29943-1:2017(E)
©
ISO 2017

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ISO 29943-1:2017(E)

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ii © ISO 2017 – All rights reserved

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ISO 29943-1:2017(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Pilot clinical studies . 2
5 Clinical validation investigation . 3
5.1 Objectives of clinical validation investigation . 3
5.2 Outcome measures . 3
5.3 Study subjects . 3
5.3.1 General. 3
5.3.2 Enrolment of study subjects . 3
5.4 Informed consent . 5
5.5 Test and control condoms . 5
5.5.1 General. 5
5.5.2 Test condom . 5
5.5.3 Control condom made from natural rubber latex . 6
5.5.4 Expiration date of control condom . 6
5.5.5 Storage conditions . 6
5.5.6 Trial duration exceeds 1 year .
...