A Pilot Functional Performances Study of The Wondaleaf-Cap and The Wondaleaf-On-Man Synthetic Male Condom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Clinical Slippage Rates (CSR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
盲法说明
Throughout the study, neither participating couples, clinic staff, research assistants or researchers are masked to condom assignment as there are observable differences on packaging and design between the test condom (WLC and WLM) and the control condom (durex-Together). However, statisticians, sponsors, and medical reviewers are masked until completion of the final report to minimize biases potentially emerge during data analyses and results reporting.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Their female sexual partners are not at risk of pregnancy (using alternate contraception);
- •They don't have known sexually transmitted infections, including HIV/AIDS;
- •They should be experienced condom users, minimum 10 male condoms used in the last 12 months;
- •They are between 18 to 45 years of age;
- •They are in a monogamous heterosexual relationship and agree to practice vaginal sex only using male condoms provided by the study.
排除标准
- •couples who work for the research team or who are close relatives of the research team;
- •men with known allergy to natural rubber latex;
- •men with known sensitivity to the residual chemicals used in the manufacture of natural rubber latex condoms or the test condom materials;
- •couples where one knowingly has a sexually transmitted infection.
- •couples who are pregnant in time of recruitment
结局指标
主要结局
Clinical Slippage Rates (CSR)
时间窗: 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
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.
Clinical Breakage Rates (CBR)
时间窗: 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
Number of condoms that broke during intercourse or withdrawal, divided by the number of condoms used during intercourse; reported as a percentage.
Clinical Failure Rates (CFR)
时间窗: Through study completion, an average of 3 months. In specific, CFR will be calculated after completion of four times usage, for each condom type
CFR is the sum of CSR and CBR for each condom type
次要结局
- 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)
- 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)
- 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)
- 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)