NCT04134039已完成4 期
A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Compared clinical failure rate of condom use between the test condom group and the reference condom group
研究概览
简要总结
This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.
详细描述
In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Each condom will be individually wrapped in its primary packet then be put in an identical box. All branding will be masked.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male and a female subject aged: 18 - 60 years inclusive.
- •All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
- •All couples must be sexually active and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks).
- •The female partner should already be on an established highly effective form of non-barrier contraception, unless post-menopausal.
- •Couples must agree not to use drugs or non-investigational devices that can affect sexual performance.
排除标准
- •Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or reference condoms.
- •Either partner has a pre-existing skin condition (severe eczema/ psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination.
- •Either partner that needs to use condoms for a specific sexually transmitted infection (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.
- •Subjects that have previous or planned genital surgery, that in the opinion of the Investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear.
- •Male partners that have known erectile or ejaculatory dysfunction.
- •A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the investigator, deems the partner unsuitable for the investigation.
- •Any subject who has clinical symptoms or signs of a sexually transmitted diseases (STD) or HIV/ AIDS or has a previous history of high-risk behaviour as judged by the investigator.
- •Female partner using medication which in the investigator's opinion would affect vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use.
- •A male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse.
- •Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.
结局指标
主要结局
Compared clinical failure rate of condom use between the test condom group and the reference condom group
时间窗: within 2 hours following each coital act for each condom use
Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects.
次要结局
- Performance (clinical slippage rate) of the Polyurethane (PU) condom(within 2 hours following each coital act for each condom use)
- Subject's experience on the use of each type of condoms [Acceptability and Tolerability(12 weeks)
- Performance (clinical breakage rate) of the Natural Rubber Latex (NRL) condom(within 2 hours following each coital act for each condom use)
- Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3(12 weeks)
- Performance (clinical breakage rate) of the Polyurethane (PU) condom(within 2 hours following each coital act for each condom use)
- Performance (clinical slippage rate) of the Natural Rubber Latex (NRL) condom(within 2 hours following each coital act for each condom use)
研究者
研究点 (1)
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