Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Total Clinical Failure Rate
研究概览
简要总结
This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.
详细描述
Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Each product will be labeled with a randomly generated code.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give written or electronic informed consent
- •Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews
- •Agree to have vaginal intercourse at least once weekly
- •Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- •Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry
- •In a mutually monogamous relationship with participant's study partner for at least 3 months prior to screening and be willing to remain mutually monogamous throughout study participation
- •Agree not to use any vaginal or sexual lubricant except the product supplied by the study (AstroglideTM)
- •Agree not to wear any genital piercing jewellery while using the study condoms
- •Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
- •Agree to return any unopened condoms
- •Reachable by telephone
- •Has home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
- •Male partner agrees to ejaculate during vaginal intercourse
排除标准
- •Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
- •Female partner self-reported as pregnant
- •Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products
- •Unable to follow instructions or strictly adhere to the visit schedule
- •At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia)
- •Currently using condoms for protection against a known sexually transmitted infection
- •Taking any externally applied medication or oral medication to treat a genital condition
- •Male partner has had difficulty achieving or maintaining an erection or achieving ejaculation in the last month prior to screening under typical circumstances/ conditions.
- •Any self-reported genital condition (e.g., itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect the use of the study condoms or the ability to interpret study data
结局指标
主要结局
Total Clinical Failure Rate
时间窗: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
The number of condoms that broke or slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
次要结局
- Clinical Breakage Rate(Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.)
- Clinical Complete Slippage Rate(Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.)