Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Total Clinical Failure
研究概览
简要总结
This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.
详细描述
Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom.
The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms, as well as perceptions about using the devices.
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
- Double (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
- •Between the ages of 18 and 45 (inclusive)
- •Willing and able to give written or electronic informed consent
- •Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
- •Be sexually active (defined as averaging one vaginal coital act per week)
- •Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- •Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry
- •In a mutually monogamous relationship with their study partner for at least 3 months 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
- •Agree not to wear any genital piercing jewelry 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, reachable by phone, ability to videoconference and use electronic consent technology
- •Male partner agrees to ejaculate during vaginal intercourse
- •Willing to provide photo identification-
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 polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
- •Unable to follow instructions or strictly adhere to the visit schedule
- •At significant (high) risk of sexually transmitted infections, including 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 internally 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 under typical circumstances/ conditions.
- •Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data -
结局指标
主要结局
Total Clinical Failure
时间窗: 5 -7 weeks
The total clinical failure rate is defined as the number of condoms that broke or slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
次要结局
- Clinical Breakage(5 - 7 weeks)
- Clinical Complete Slippage(5-7 weeks)