Wondaleaf is currently undergoing clinical trials with the aim of establishing its efficacy as a barrier contraceptive, and its utility in menstrual control. These trials further have the aim of establishing the acceptability and usability of this device, and will be used in the Malaysian Device Authority, US Food and Drug Agency, Australian Therapeutic Goods Administration and other regulatory agency device approval processes.
The clinical trial to assess the performance of Wondaleaf® as a female barrier contraceptive method among healthy volunteer married couples is conducted by Clinical Research Centre of Sibu Hospital, led by A/Prof. Dr Toh Teck Hock and Dato Dr Ong Loke Meng. The study also aims to determine the acceptability and satisfaction of use of Wondaleaf® by subjects and their spouses, as well as its safety profile. The study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (NMRR-15-333-24953), and registered on the ClinicalTrials.gov (NCT02593214). For more information about this study, please contact Ms Yap Ling of Clinical Research Centre, Sibu Hospital at 084-314569 or email her at yapling@clinicalresearch.my,.
Trial protocols for ongoing trials are summarised below