A Functional Performance Study of The Wondaleaf Female Condom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Total clinical failure
研究概览
简要总结
This research study will determine how well two female condoms perform when used during sex. One of these condoms (FC2) is already commercially available in South Africa. The other female condom, "Wondaleaf Condom" is a new female condom. Participants will use both condoms. The study aims to determine how well these condoms work comparatively. Study visits include a screening/enrolment visit and 2 follow up visits.
详细描述
This research study will determine how well two female condoms perform when used during sex. One of these condoms (FC2) is already commercially available in South Africa. The other female condom, "Wondaleaf Condom" is a new female condom. Participants will use both condoms. The study aims to determine how well these condoms work comparatively.
The Wondaleaf female condom is a new female condom (FC) design made of polyurethane with no external or internal rings. The body of the condom is fitted by an exterior adhesive shield which also displays the condom when removed from the condom packaging.
Purpose: To ascertain the functional performance of the Wondaleaf FC. This research study will be a two-period, cross-over randomized controlled trial to compare the functional performance, safety and acceptability of two FC types.
Study Design: The study will enrol 220 women, anticipating that 200 participants complete the study. The age range of these participants is from 18-45 years. Each participant will be asked to use five Wondaleaf FCs and five FC2 female condoms (available in the South African public sector).
Primary endpoints will be total clinical failure and total device failure for each condom type. Secondary endpoints will include rates of invagination, complete slippage, misdirection, and breakage.
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
The two devices in the trial are distinctly different and so device specific training is required and so cannot be blinded. The statistician analysing the data will be blinded to female condom type.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 18 and 45 years (inclusive);
- •Be literate (able to read a newspaper or letter easily);
- •Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
- •Be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study;
- •Have been in a sexual relationship with this partner for at least 6 months;
- •Not be a sex worker;
- •Not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study;
- •Be without observable evidence of Sexually Transmitted Infections (STI) as determined through syndromic diagnosis and vaginal examination;
- •Be using hormonal or other non-barrier contraception (e.g. Oral Contraception (OCs), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
- •Not be menopausal (defined as 12 months without menstruation);
- •Not have had a hysterectomy;
- •Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
- •Willing to give informed consent;
- •Willing to complete the FC 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 10 condom uses (approximately 2-4 months.
- •Willing to have fingerprint scan to check for co-enrolment in other research projects
排除标准
- •None specified
结局指标
主要结局
Total clinical failure
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Total clinical failure is defined as the sum of female condoms that clinically break or slip, or are associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment which results in the reduction of the female condom protective function. The total clinical failure rate is calculated by dividing the number of female condoms with a clinical failure by the number of female condoms used during sexual intercourse.
Clinical breakage
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the female condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of female condoms reported to have broken during sexual intercourse or during withdrawal by the number of female condoms used during sexual intercourse.
Total breakage
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Total breakage is defined as the sum of all female 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 female condoms that broke by the number of female condom packages opened
Slippage
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Slippage is defined as an instance when a female condom slips completely out of the vagina during sexual intercourse. The slippage rate is calculated by dividing the number of female condoms that slipped by the number of female condoms used during sexual intercourse.
Misdirection
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Invagination is defined as an instance when the external retention feature of the female condom is partially or fully pushed into the vagina during sexual intercourse. The invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse.
Invagination
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Invagination is defined as an instance when the external retention feature of the female condom is partially or fully pushed into the vagina during sexual intercourse. The invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse.
Total female condom failure
时间窗: Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)
Total female condom failure is defined as a female condom for which a non-clinical breakage, clinical breakage or slippage occurs, or is associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment. The female condom failure rate is calculated by dividing the number of female condoms that fail by the number of female condom packages opened.
次要结局
- Safety (Adverse Events)(Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks))
- Acceptability(Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks))
研究者
Prof Mags Beksinska
Deputy Executive Director
University of Witwatersrand, South Africa