NCT03324594: WONDALEAF-MEN

A Pilot Functional Performances Study of Two Synthetic Male Condom

Completed NA Last updated 18 July 2018

What this trial tests

NA trial testing (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator) in Functional Performance in 50 participants. Completed in 31 March 2018.

Timeline

1 November 2017

Primary endpoint
31 March 2018

31 March 2018

Quick facts

Lead sponsor	Clinical Research Centre, Malaysia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	device feasibility
Enrollment	50
Start date	1 November 2017
Primary completion	31 March 2018
Estimated completion	31 March 2018
Sites	2 locations across Malaysia

Drugs / interventions tested

• (1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)

Conditions studied

• Functional Performance — all drugs for Functional Performance →
• Synthetic Male Condom — all drugs for Synthetic Male Condom →

Sponsor

Clinical Research Centre, Malaysia

Who can join

Adults 18 to 45, male only, with Functional Performance or Synthetic Male Condom. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over the decades, male condoms had been widely commercialized and used to protect against unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex (NRL) male condoms has majority proportion of male condoms in the market, synthetic male condoms (SMC) made from polyurethane or other synthetic materials remain new to the consumers. Notably, synthetic male condoms are found to be more durable, non-allergenic and have better compatibility with lubricants when compared to NRL male condoms. The SMCs that have FDA approval and commercially available are AvantiTM (polyisoprene condom), Trojan SupraTM (polyurethane condom) and eZ.onTM (polyurethane condom). Although the effectiveness of SMCs in the prevention of sexually transmitted infections has yet to be established, SMCs are believed to be comparable to NRL male condoms in both STI prevention and contraception protection. Notwithstanding, a recent literature had reported the shortfall on the quality of variant male condoms in the market, especially nonconforming volumetric capacity, burst pressure and freedom from holes. This warrant the current investigation, to evaluate the functional performances of two newly invented synthetic male condoms, branded as "WONDALEAF-CAP" (WLC) and "WONDALEAF-ON-MAN" (WLM). Apart from being made of polyurethane, the major feature of WLC and WLM are nonetheless their adhesive coating on the outer rim of the condom opening which by securely adhering to the foreskin, prevent slippage of condom and spillage of male ejaculate or secretions when the penis is flaccid, and thereby improve the user-friendliness of condom usage.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.