NCT01755741已完成1 期
A Multicenter, Open-Label, Randomized, Two-Period, Crossover Non-inferiority Trial to Assess the Functionality of Male Condoms With a Silicone Elastomer Vaginal Ring
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Total clinical failure rate (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse.
研究概览
简要总结
This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the 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 55 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 condoms provided by trial personnel during the time of participation. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
- •Agree to not use 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 to natural latex or vaginal lubricants such as Astroglide ®;
- •History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
- •Currently using 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.
结局指标
主要结局
Total clinical failure rate (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse.
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
已完成
早期 1 期
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery MethodHIV InfectionsNCT00469170International Partnership for Microbicides, Inc.220
已完成
3 期
Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)Contraception: Optional Applicator for Insertion of Vaginal RingNCT02275546Organon and Co164
Unknown
1 期
A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling WomenOvulation InhibitionNCT02451826Population Council19
尚未招募
1 期
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal InsertPre Term BirthNCT06668896Daré Bioscience, Inc.60
已完成
2 期
Assessment of a Vaginal Ring With Meloxicam in the Treatment of DysmenorrheaDysmenorrheaNCT02255045Laboratorios Andromaco S.A.68