Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

September 24, 2017

Completed

1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed

5 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed

Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

September 24, 2017

Last Update Submit

July 16, 2018

Conditions

Functional Performance Synthetic Male Condom

Keywords

functional performancesynthetic male condom

Outcome Measures

Primary Outcomes (3)

Clinical Slippage Rates (CSR)
Number of condoms that slipped completely off the penis during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Through study completion, an average of 3 months. In specific, CSR will be evaluated within 24 hours after use of individual condom, for each condom type
Clinical Breakage Rates (CBR)
Number of condoms that broke during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Through study completion, an average of 3 months. In specific, CBR will be evaluated within 24 hours after use of individual condom, for each condom type
Clinical Failure Rates (CFR)
CFR is the sum of CSR and CBR for each condom type
Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type

Secondary Outcomes (5)

Incidence of Treatment-Emergent Adverse Events
Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Comfort in use
Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Ease of insertion and removal
Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Favorability of product attributes
Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type
Adequacy and feel of lubrication
Through study completion, an average of 3 months. In specific, it will be measured after completion of four times usage, for each condom type

Study Arms (6)

Group A

ACTIVE COMPARATOR

Participants will be first given (1) WONDALEAF-CAP, followed by (2) WONDALEAF-ON-MEN, and last with (3) durex-TOGETHER after completion of four times usage for each condom type. The participants will be asked to complete four times of usage for each condom type within three to four months. There will be a baseline survey before the use of the first condom type, and subsequent evaluations upon completion of each condom type.