A Pilot Functional Performances Study of Two Synthetic Male Condom

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 1, 2017

Primary Completion Date

March 31, 2018

Study Completion Date

March 31, 2018

Conditions
Functional PerformanceSynthetic Male Condom
Interventions
DEVICE

(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."

Trial Locations (2)

93400

Sarawak Family Planning Association, Kuching

94200

Sarawak Research Society, Kuching

All Listed Sponsors
collaborator

Twin Catalyst Sdn. Bhd.

INDUSTRY

collaborator

Sarawak Research Society

UNKNOWN

lead

Clinical Research Centre, Malaysia

OTHER