ISO 29943-1:2017

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 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

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 . 6
5.5.7 Sampling of control condoms for bench testing . 6
5.6 Randomization . 6
5.7 Allocation concealment and study masking . 7
5.8 Use of additional lubricant . 7
5.9 Instructions and interactions with study couples . 7
5.10 Interviews and data collection . 8
5.10.1 Schedule for interviews and condom distribution . 8
5.10.2 Enrolment interview . 8
5.10.3 Individual condom use CRF . 8
5.10.4 Mid-study CRF, crossover trial . 9
5.10.5 Compiling data from CRFs . 9
5.11 Data integrity .10
5.11.1 General.10
5.11.2 Interactive voice response systems (IVRS) .10
5.11.3 Mail-in and web-based data reporting .10
5.11.4 Web-based data collection systems and additional suggestions .11
5.12 Control of distribution chain .11
5.13 Analysis of returned condoms .12
5.14 Other methodological details .12
5.15 Statistical analysis plan .12
5.15.1 General.12
5.15.2 Primary study hypothesis .13
5.15.3 Secondary study hypotheses .13
5.15.4 Study design .13
5.15.5 Statistical analysis . .14
5.15.6 Additional statistical comments and concerns .14
5.16 Clinical study results: Review and interpretation .15
5.16.1 General.15
5.16.2 Total clinical failure rates for control condom .15
5.16.3 Non-inferiority .15
5.16.4 Superiority .15
5.16.5 Safety (adverse events) .15
5.16.6 What happens if one is unable to conclude non-inferiority? .16
Annex A (informative) Formula for power calculation .17
Annex B (informative) Pilot clinical investigation (sample outline) .18
Annex C (informative) Time and events schedule for individual study subject (sample) .20
Annex D (informative) CRF — Study entry (sample) .21
Annex E (informative) CRF — Mid-study (sample) .24
Annex F (informative) CRF — Individual condom use (sample).25
Annex G (informative) CRF — Adverse event (sample) .32
Annex H (informative) Protocol for evaluation of returned used condoms .34
Bibliography .41
iv © ISO 2017 – All rights reserved

Foreword
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
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URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics.
A list of all the parts of ISO 29943 can be found on the ISO website.
Introduction
Male condoms made from natural rubber latex (NRL) have a long history of safety and effectiveness and
their performance during use is well established. However, male condoms made from new materials
require clinical validation to ensure that their performance during actual use is not inferior to that of
NRL condoms. Such clinical validation studies,
...