Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
This research study aims to assess the effectiveness of three female condoms [Cupid, Cupid 2 and Female Condom 2(FC2)] for the prevention of pregnancy among women choosing the female condom (FC) as their method of fertility regulation. Participants will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage.
详细描述
This research study aims to assess the effectiveness of three female condoms (Cupid, Cupid 2 and FC2) for the prevention of pregnancy among women choosing the female condom (FC) as their method of fertility regulation.
The study is a randomized comparative prospective follow-up study. Participants will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage. The primary endpoint will be the occurrence of pregnancy or use of emergency contraception, and the diary information will allow pregnancy rates to be characterized by patterns of condom use and failures (contraceptive efficacy and effectiveness rates).
The target population will be 780 urban and peri urban, sexually active women who are experienced users of FCs. Recruitment will be from a family planning clinic associated with the MatCH Research Unit (MRU), University of the Witwatersrand, Durban, South Africa and the surrounding community. The woman rather than the couple will be the unit of observation since the major outcome to be measured is pregnancy. There will be monthly follow-ups of participants from enrollment until after the 6th menstrual cycle (month 1,2,3,4,5 and 6). All visits will be conducted at the research site. The diary, to be completed on a daily basis by the participants, will indicate whether the coital frequency differs significantly between subgroups (students, urban, peri-urban).
Female clients of the Commercial City Clinic and other women presenting at the site will be informed about the study. If a potential participant expresses interest in participating, she will be given the study information sheet to read, which will describe the study requirements and her potential role in the study. If she agrees to take part in the research, she will be asked to provide written informed consent. The participant will be administered the screening form to determine whether she meets study inclusion criteria.
Eligible women who agree to participate will undergo a baseline interview. Information collected during the enrollment interview will include demographic data and information on the participant's general and reproductive health. The data collected on reproductive health variables will include the date of last menstrual period (LMP), history of pregnancies, births and miscarriages, a contraceptive history as well as a sexual history. After completion of the interview, the participant will be randomized to the use on one FC type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The three condoms in the trial are distinctly different and so condom 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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy sexually active women who have ever used an FC and using condoms (male or female) as their current method of contraception.
- •Be 18 to 40 years at enrolment (inclusive).
- •Have a negative urine pregnancy test at enrolment visit.
- •Is HIV negative
- •Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using hormonal contraception.
- •Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
- •Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
- •Be willing to accept a risk of pregnancy.
- •Reporting to have at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
- •Be willing to only use the study product (Cupid or FC2 female condom) as the primary method of contraception over the course of the study.
- •Be capable of using the study product properly and agree to observe all study directions and requirements.
- •Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and details of condom use and any condom failures.
- •Be willing to state that, to her best knowledge, her sexual partner:
- •Has not had a vasectomy or been previously diagnosed as infertile.
- •Is HIV negative
- •Has no known history of allergy or sensitivity to natural rubber latex, water-based or silicone lubricants
- •Does not want her to become pregnant in the next 7 months
- •Agree to have fingerprint identity check
- •Be willing to give written informed consent to participate in the trial.
- •Intend to stay in the area for the next 6-7 months
- •Be willing to be randomized
排除标准
- •Have a history of allergy or sensitivity to rubber latex or water-based /silicone lubricants
- •Have evidence of sexually transmitted infections on syndromic assessment and / or vaginal examination
- •Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
- •Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
- •Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
- •Be in a monogamous relationship of less than 4 months with their partner.
- •Have any contraindications to pregnancy (medical condition) or regularly use medications that are unsafe to use in pregnancy
- •Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use.
- •HIV positive.
- •Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within 3 months prior to screening or have clinical evidence of HSV on exam.
- •Be lactating or breastfeeding.
- •Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
- •Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
- •Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment.
- •Have received a Depo-Provera® injection in the 6 months prior to enrolment or Nur-Isterate in the last 4 months prior to enrolment
- •Have a past (within 12 months) or current history of alcohol or drug [recreational, prescription or over-the-counter (OTC)] abuse.
- •Have taken an investigational drug or used an investigational device within the past 30 days.
- •Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
结局指标
主要结局
Pregnancy
时间窗: 6-7 months
The main outcome measure of the study is the occurrence of pregnancy, which will be used to estimate the overall effectiveness of the method. For the overall pregnancy rate all pregnancies will be counted regardless of the reason(s) for the failure. Pregnancy rates will be computed using life table techniques. If the pregnancy rates are reasonably constant with time, then the Pearl index (pregnancies per 100 years of use) will be used and confidence intervals estimated from the Poisson distribution. Discrete time life-table methods will be used to explore patterns of failures associated with correct, incorrect and non-use of condoms (in each interval subjects will be classified according to the type or pattern of condom use and the life-table or Pearl rates computed for each stratum). Failure modes associated with the use of the female condoms per act of intercourse in which a FC was used.
次要结局
- Non-clinical breakage(6-7 months)
- Slippage(6-7 months)
- Total clinical failure(6-7 months)
- Total female condom failure(6-7 months)
- Clinical breakage(6-7 months)
- Invagination(6-7 months)
- Total breakage(6-7 months)
- Misdirection(6-7 months)
研究者
Prof Mags Beksinska
Deputy Executive Director
University of Witwatersrand, South Africa