50
Participants
Start Date
November 1, 2017
Primary Completion Date
March 31, 2018
Study Completion Date
March 31, 2018
(1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)
"1. WONDALEAF-ON-MEN (WLM) is a polyurethane pouch with outstretching adhesive shield. The pouch covers the penis in man user; while the adhesive shield covers the groin regions to provide extra protection for the couples. The pouch is equivalent to marketed polyurethane male; while the adhesive shield is equivalent to marketed polyurethane wound dressing. WLM integrally joined with an adhesive wound dressing, both made of the same polyurethane material.~2. WONDALEAF-CAP (WLC) is a miniature form of WLM: the pouch covers glans penis and the adhesive shield wraps around the shaft of the penis only, thereby emulating the configuration of a donned regular condom on the penis. Because of the adhesive coating, WLC overcomes the problems of slippage when the penis is flaccid.~3. The durex-TOGETHER serves as the active comparator in this study. It is a transparent natural rubber latex male condom which is commercially available."
Sarawak Family Planning Association, Kuching
Sarawak Research Society, Kuching
Lead Sponsor
Twin Catalyst Sdn. Bhd.
INDUSTRY
Sarawak Research Society
UNKNOWN
Clinical Research Centre, Malaysia
OTHER