NCT01755754已完成1 期
A Multicenter, Open-label, Randomized, Two-period, Crossover Non-inferiority Trial to Assess the Functionality of Female Condoms With a Silicone Elastomer Vaginal Ring
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Total clinical failure rate
研究概览
简要总结
A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess the functionality of female condoms with a silicone elastomer vaginal ring.
详细描述
This was an open-label, randomized, 2-period, crossover non-inferiority trial, conducted over 4.5 months at two research centers in the USA among 81 healthy, monogamous, heterosexual, sexually active couples to assess the functionality of female lubricated, nitrile condoms during vaginal intercourse in the presence and absence of a silicone elastomer placebo vaginal ring.
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
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
- •Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
- •Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
- •Healthy on the basis of medical history;
- •Not at risk of pregnancy, i.e., female is surgically sterile, using an IUD, or using effective hormonal contraception, or has a vasectomized partner. The use of vaginal contraceptive rings will not be allowed;
- •Sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each;
- •Agree to use only the female condoms provided by trial personnel during the time of participation and not to use male condoms during the trial. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
- •Agree to not use genital jewelry or other vaginal products, except menstrual absorption products (e.g., tampons) and study lubricant during the trial;
- •Available for all visits and consent to follow all procedures scheduled for the trial;
- •At low risk for HIV infection.
排除标准
- •Males with untreated erectile dysfunction;
- •Female with positive pregnancy test;
- •Either partner allergic or hypersensitive to vaginal lubricants such as Astorlige ®
- •Either partner not willing to refrain from wearing genital piercing jewelry for the duration of the study
- •History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
- •Consistently using male or female condoms for protection against sexually transmitted infection;
- •Either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil);
- •Either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the Investigator, could affect use of the study condoms or ability to interpret trial data;
- •Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.)
- •Current participation in a study or other research involving a drug, device or other product;
- •Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
研究组 & 干预措施
Silicone Elastomer Vaginal Ring
Experimental
Silicone Elastomer Vaginal Ring
干预措施: Silicone Elastomer Vaginal Ring (Combination Product)
Female Condom
Experimental
This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring
干预措施: Silicone Elastomer Vaginal Ring (Combination Product)
Female Condom
Experimental
This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring
干预措施: Female Condom (Device)
结局指标
主要结局
Total clinical failure rate
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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