A Functional Performance and Acceptability Study of a Synthetic Nitrile Male Condom, and a Latex Graphene Male Condom Compared to a Standard Latex Male Condom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Slippage
研究概览
简要总结
Two new male condoms have been developed - one made of synthetic nitrile and the other made of latex graphene. Both new condoms are of the same design as a standard latex male condom. The aim of this study is to evaluate the functional performance of two new male condoms compared to a control latex male condom. Couples enrolled in the study will be asked to use five latex graphene, five synthetic nitrile and five latex male condoms in a randomized type order. Function, safety, and acceptability will be assessed at three follow-up visits approximately one month apart after enrolment.
详细描述
Two new male condoms have been developed - one made of synthetic nitrile and the other made of latex graphene. Both new condoms are of the same design as a standard latex male condom.
Purpose: The aim of the study is to evaluate the functional performance of two new male condoms compared to a control latex male condom.
Study design: The study is a randomized three-period cross-over trial of two new male condoms and a control latex male condom. The study will enrol 240 couples, anticipating that at least 200 couples will complete the study. Each couple will be asked to use five latex graphene, five synthetic nitrile and five latex male condoms in a randomized type order. Function, safety, and acceptability will be assessed at three follow-up visits approximately one month apart after enrolment. Couples will complete a Condom Log at their homes which gathers data on experience after use of each condom.
Primary Objective: To ascertain the functional performance of a latex graphene and a synthetic nitrile compared to a control latex male condom. Primary endpoints will be total clinical failure and total condom failure.
Secondary Objectives: Acceptability and safety data (as determined by the number of adverse events) occurring with each male condom type.
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
- Single (Outcomes Assessor)
盲法说明
Analysts will be blinded until all data have been captured and the primary analysis programs have been verified. Likewise, all reasonable attempts will be made to keep other non-monitor staff blinded during the course of the study. The statistician analyzing the data will not be blinded. Due to slight differences related to colour of the study products, it will not be possible to blind participants and clinic staff associated with the project
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
- •All couples enrolled in this research must meet the following selection criteria:
- •Be between the ages of 18 and 45 years (inclusive);
- •Be literate (able to read a newspaper or letter easily);
- •Have been in an exclusive (monogamous) sexual relationship with partner for at least 6 months; and intend to continue to be an exclusive (monogamous) sexual relationship with partner with their spouse or partner while participating in this research study;
- •Not planning a pregnancy during the time of the research study;
- •Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
- •Not have any genital piercings, use genital beading or any other drugs or non-study devices that can affect sexual performance;
- •Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
- •Be without observable evidence of Sexually transmitted infections (STI) as determined through syndromic diagnosis and vaginal/penile examination;
- •Not be HIV positive
- •Willing to give informed consent;
- •Willing to complete the male condom coital use logs;
- •Willing to use the study condoms as directed;
- •Willing to adhere to the follow-up schedule and all study procedures;
- •Willing to provide research study staff with an address, phone number or other locator information while participating in the study; and,
- •Willing to participate in the study for the duration of 15 condom uses (approximately 3- 5 months.
- •Willing to have fingerprint scan to check for co-enrolment in other research projects Female partner only: -
- •Using hormonal or other non-barrier contraception (e.g. Oral Contraceptives (OC), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
- •Must not be pregnant (as determined by pregnancy testing)
- •Not be menopausal (defined as 12 months without menstruation);
- •Not have had a hysterectomy; Male partner only: -
- •Not have known erectile or ejaculatory dysfunction.
排除标准
- 未提供
结局指标
主要结局
Slippage
时间窗: 3-5 months
Slippage is defined as an instance when a male condom slips completely off the penis during sexual intercourse or during withdrawal from the vagina. The slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during sexual intercourse.
Non-Clinical breakage
时间窗: 3-5 months
Defined as breakage noticed before sexual intercourse or occurring after withdrawal of the male condom from the vagina. Non-clinical breakage is breakage with no potential adverse clinical consequences. The non-clinical breakage rate is calculated by dividing the number of male condoms reported to have broken before sexual intercourse or after withdrawal by the number of male condom packages opened
Total male condom failure
时间窗: 3-5 months
Total male condom failure is defined as a male condom for which a non-clinical breakage, clinical breakage or slippage occurs, or is associated with any additional failure modes(s) identified in the risk assessment. The male condom failure rate is calculated by dividing the number of male condoms that fail by the number of male condom packages opened
Clinical breakage
时间窗: 3-5 months
Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken during sexual intercourse or during withdrawal by the number of male condoms used during sexual intercourse.
Total breakage
时间窗: 3-5 months
Total breakage is defined as the sum of all male condom breakages at any time before, during or after sexual intercourse. It includes both clinical breakages and non-clinical breakages. The total breakage rate is calculated by dividing the total number of male condoms that broke by the number of male condom packages opened.
Total clinical failure
时间窗: 3-5 months
Total clinical failure is defined as the sum of male condoms that clinically break or slip, or any additional failure modes(s) identified in the risk assessment which results in the reduction of the male condom protective function. The total clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during sexual intercourse.
次要结局
- Acceptability assessed by the frequency of key acceptability endpoints(3-5 months)
- Safety assessed by genitourinary adverse events(3-5 months)
研究者
Prof Mags Beksinska
Deputy Executive Director
University of Witwatersrand, South Africa