Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- The exploration of condom experience across a range of sizes and materials
研究概览
简要总结
The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials.
详细描述
In this investigation, 4 Polyurethane (PU) condom variants and 4 Natural Rubber Latex (NRL) condom variants will be tested by participants to explore condom experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Although it is an open label investigation, some information such as condom size will be removed from all packages so participants will not know which condom variant they are testing.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent before participation in the clinical investigation.
- •Cisgender male, aged 18 - 55 years.
- •In the opinion of Investigator, experienced user of condoms who use condoms to prevent pregnancies and / or contracting STIs.
- •Able and willing to achieve a penile erection following self-stimulation.
- •Able and willing to masturbate with a PU or NRL condom on.
- •Agree to use only lubricant provided by the study for use with IMDs, if required.
- •Agree not to wear any genital piercing jewelry while using the study condoms.
- •Agree not to use sex toys, consume alcohol or use drugs intended to enhance or diminish sexual response when using study condoms.
- •Agree to perform erected penis size measurement at site and at home.
排除标准
- •Participants with known trouble attaining or maintaining an erection.
- •Participants presenting clinically abnormal findings on the penis that in the opinion of the investigator can affect the study outcome.
- •Participants with an allergy or sensitivity to the ingredients of the test products, including the test condoms or any lubrication products provided.
- •Use of any topical medications applied to the penis between screening and visit
- •Participants with diagnosed or suspected erectile dysfunction.
- •Participants with a history of prostatectomy.
- •Participants with a history of urethral surgery.
- •Participants with any other congenital or acquired genital abnormalities (e.g. peyronies disease, hypospadias, intersex, phimosis, penile cancer).
- •Psychiatric conditions that might limit the participation in the clinical investigation and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
- •Participants with any medical condition in the opinion of the investigator which poses a risk to the participant or is detrimental to the objectives of the clinical investigation.
- •Participants who should not participate in the clinical investigation for any other reason as judged by the investigator.
- •Participation in a pharmaceutical trial with investigational products or in a clinical investigation with another medical device within the last 30 days prior to the visit 2 (day 1) and / or during this clinical investigation.
- •Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company.
结局指标
主要结局
The exploration of condom experience across a range of sizes and materials
时间窗: 6 weeks condom use period (intervention duration)
Participants will measure their penis size at screening and will be assigned to pre-defined groups. The endpoint is the exploration of condom experience across a range of materials and sizes within each group. Participants will evaluate the condoms over a period of 6 weeks and rate their condom experience through subject perceived questionnaires using the following scales: 1. Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree; 2. 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.
次要结局
- Examine whether the preferred condom variant is the same for both PU and NRL condoms.(6 weeks condom use period (intervention duration))