Performance and Safety Trial of an Innovative Female Condom (Wondaleaf®)

Phase:Open Label
Principal Investigator(s):Teck-Hock Toh, Loke-Meng Ong, Shirin Hui Tan, Sing Hong Chuo
Objective:General objective: To assess the performance and safety profile of a novel innovative design of female condom (Wondaleaf®) among healthy married women. Specific objectives : To determine the failure rate of Wondaleaf®, in terms of clinical breakage, non-clinical breakage, invagination, misdirection, and slippage.To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and their spouses.To assess the safety profile of Wondaleaf®.
Prevention Option(s):Condoms, MPTs
Study Design:Open label
Official Code: NCT02593214
Trial Sponsors: Clinical Research Centre, Malaysia Twin Catalyst Sdn. Bhd.
Start Date
End Date
August 3, 2015
September 3, 2016
Age range: 21 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women