Functional performance of the Wondaleaf condom: A crossover, noninferiority, randomized clinical trial

Abstract

Background New female condom (FC) products wishing to apply for United Nations Population Fund/World Health Organisation (UNFPA/WHO) prequalification are required to conduct a randomized, controlled clinical investigation comparing the new FC to the marketed FC, in order to comply with UNFPA/WHO and International Organization for Standardization (ISO) specifications. We aimed to assess the functional performance, acceptability and safety of the Wondaleaf female condom compared to the control FC2 female condom. Methods This randomized clinical trial enrolled 220 women in one South African site. The primary outcome of the study was the rate of female condom (FC) failure. Participants were asked to use five of each FC type and to collect information on use in a condom diary at home, and were interviewed after use of each FC type. Results Noninferiority was demonstrated for the Wondaleaf with respect to the reference FC2 for all condom functions. The Wondaleaf was found to be superior to the FC2 reference condom for invagination ( p > .000), misdirection ( p > .000) and clinical failure ( p > .000). Acceptability ratings for a range of features were similar between the two FCs. Few safety events were reported for either device. Conclusion The Wondaleaf performs as well as the FC2, and is equally acceptable. Results from this study will inform further refinement of this FC design. Trial registrations: ClinicalTrials.gov Identifier: NCT04076774 https://clinicaltrials.gov/ . South African National Clinical Trials Database (SANCTR) number DOH-27-0319-6020