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.<\/p>\n
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).<\/p>\n
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.<\/p>\n
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 .<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 4 Pilot clinical studies <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 5 Clinical validation investigation 5.1 Objectives of clinical validation investigation 5.2 Outcome measures 5.3 Study subjects 5.3.1 General 5.3.2 Enrolment of study subjects <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 5.4 Informed consent 5.5 Test and control condoms 5.5.1 General 5.5.2 Test condom <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5.5.3 Control condom made from natural rubber latex 5.5.4 Expiration date of control condom 5.5.5 Storage conditions 5.5.6 Trial duration exceeds 1 year 5.5.7 Sampling of control condoms for bench testing 5.6 Randomization <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5.7 Allocation concealment and study masking 5.8 Use of additional lubricant 5.9 Instructions and interactions with study couples <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.10 Interviews and data collection 5.10.1 Schedule for interviews and condom distribution 5.10.2 Enrolment interview 5.10.3 Individual condom use CRF <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.10.4 Mid-study CRF, crossover trial 5.10.5 Compiling data from CRFs <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.11 Data integrity 5.11.1 General 5.11.2 Interactive voice response systems (IVRS) 5.11.3 Mail-in and web-based data reporting <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.11.4 Web-based data collection systems and additional suggestions 5.12 Control of distribution chain <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.13 Analysis of returned condoms 5.14 Other methodological details 5.15 Statistical analysis plan 5.15.1 General <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.15.2 Primary study hypothesis 5.15.3 Secondary study hypotheses 5.15.4 Study design <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.15.5 Statistical analysis 5.15.6 Additional statistical comments and concerns <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.16 Clinical study results: Review and interpretation 5.16.1 General 5.16.2 Total clinical failure rates for control condom 5.16.3 Non-inferiority 5.16.4 Superiority 5.16.5 Safety (adverse events) <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.16.6 What happens if one is unable to conclude non-inferiority? <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex\u00a0A (informative) Formula for power calculation <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Annex\u00a0B (informative) Pilot clinical investigation (sample outline) <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex\u00a0C (informative) Time and events schedule for individual study subject (sample) <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annex\u00a0D (informative) CRF\u00a0\u2014 Study entry (sample) <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex\u00a0E (informative) CRF\u00a0\u2014 Mid-study (sample) <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex\u00a0F (informative) CRF\u00a0\u2014 Individual condom use (sample) <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Annex\u00a0G (informative) CRF\u00a0\u2014 Adverse event (sample) <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Annex\u00a0H (informative) Protocol for evaluation of returned used condoms <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Condoms. Guidance on clinical studies – Male condoms, clinical function studies based on self-reports<\/b><\/p>\n |