Randomized crossover trial comparing the eZ.on plastic condom and a latex condom

Area of Science:

• Reproductive Health
• Medical Device Technology
• Public Health

Background:

• Latex condoms are standard but can cause allergic reactions.
• Non-latex condom development aims to provide alternatives for individuals with latex allergies or sensitivities.
• Assessing the performance and acceptability of new condom materials is crucial for public health initiatives.

Purpose of the Study:

• To compare the clinical breakage and slippage rates of the polyurethane bi-directional eZ.on condom against a standard latex condom.
• To evaluate the safety and user acceptability of the eZ.on condom.
• To determine if the eZ.on condom meets predefined equivalence criteria for breakage and slippage compared to latex condoms.

Main Methods:

• A randomized crossover trial involving 360 couples.
• Participants used both eZ.on and latex condoms for a specified period.
• Data collected on condom breakage, slippage, safety, and user preference.

Main Results:

• The eZ.on condom exhibited a higher clinical breakage rate (5.6%) than the latex condom (0.9%), failing to meet the a priori equivalence definition for breakage.
• Slippage rates were similar between the eZ.on (1.6%) and latex (0.7%) condoms, meeting the equivalence definition.
• The eZ.on condom demonstrated a good safety profile, was easier to don and remove, and was strongly preferred by nearly 30% of users.

Conclusions:

• The eZ.on condom is not equivalent to latex condoms regarding clinical breakage rates.
• Equivalence was demonstrated for slippage rates, indicating comparable performance in this aspect.
• The eZ.on condom presents a potentially acceptable alternative for individuals unable or unwilling to use latex condoms due to its usability and user preference among some participants.