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

Status
Completed
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)
Male and Female Condoms
Multipurpose Prevention Technologies
Study Design
Open label
Arms and Assigned Interventions
Description
Experimental: Wondaleaf Arm This is a single arm clinical trial, all subjects and their married couples were be recruited to the arm using investigational device only.
ARMs
Experimental
Trial Sponsors
Clinical Research Centre, Malaysia Twin Catalyst Sdn. Bhd.
August 2015
September 2016
Enrollment
126
21
Years
50
Years
Population
Women
Men
Sites

Sibu Hospital

Sibu
Malaysia