ISO 29943-2:2017

Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports

ISO 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms. These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use. ISO 29943-2:2017 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 — Lignes directrices relatives aux études cliniques — Partie 2: Préservatifs féminins, analyse fonctionnelle des défaillances graves sur la base d'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 29943-2
First edition
2017-07
Condoms — Guidance on clinical
studies —
Part 2:
Female condoms, clinical function
studies based on self-reports
Préservatifs — Lignes directrices relatives aux études cliniques —
Partie 2: Préservatifs féminins, analyse fonctionnelle des défaillances
graves sur la base d’auto-déclarations
Reference number
ISO 29943-2:2017(E)
©
ISO 2017

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ISO 29943-2:2017(E)

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ii © ISO 2017 – All rights reserved

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ISO 29943-2:2017(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Risk assessment . 3
5 Pilot clinical studies . 3
6 Clinical validation investigation . 4
6.1 Objectives of clinical validation investigation . 4
6.2 Outcome measures . 4
6.3 Study subjects . 4
6.3.1 General. 4
6.3.2 Enrolment of study subjects . 5
6.4 Informed consent . 6
6.5 Test and control condoms . 6
6.5.1 General. 6
6.5.2 Test condom . 7
6.5.3 Control condom . 7
6.5.4 Trial duration exceeds one year .
...