A Randomized Cross-Over Study of Vaginal Semen Exposure and Clinical Failure Comparing the PATH Woman's Condom and the FC2 Female Condom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 505
- 试验地点
- 2
- 主要终点
- Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination
研究概览
简要总结
This is a comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. California Family Health Council will enroll up to 505 couples to have 375 complete both periods. The study will provide data on functional performance, vaginal semen exposure, safety, and acceptability of the two female condoms.
Both partners will be required to come to the clinic to be consented for the study. If both members of the couple meet all eligibility requirements, they will each sign an informed consent form and will be enrolled as a couple. The couples will be randomized to one of two female condom use sequences for the two periods (WC then FC2 or FC2 then WC). For the first period of 2-4 weeks, the couple will be asked to have sex once without a condom and 4 times using the first assigned female condom. For the second period of 2-4 weeks, the couple will be asked to have sex 4 times using the second assigned female condom. In the first period, the couple will have one act of unprotected sex for which they will collect pre- and post-coital vaginal swabs. The couple will also use 4 female condoms of the assigned type. They will be asked to collect pre- and post-coital vaginal swabs and a post-coital swab from the condom interior. The couple will complete a detailed Condom Use Questionnaire together after each condom use. An Acceptability Questionnaire will be completed separately by males and females at the end of each study period. Couples may have additional acts of sex during each period as they desire but will not have sex at least 48 hours prior to each study sex act. After a follow-up visit, the procedures will be repeated with 4 of the second assigned condom type but without the collection of vaginal swabs at unprotected intercourse. Each couple will be enrolled for about 2-3 months, depending on the intervals between sex acts. Clinicians evaluating product-relatedness of AEs will be blinded to the condom type used. Male partners will be requested to attend the final visit, and, if they experience adverse events, the followup and/or unscheduled visits.
详细描述
Purpose: To compare the performance of a new female condom (PATH Woman's Condom) with an FDA-approved female condom (FC2), as assessed by reported clinical failure and vaginal PSA
Design: This is a comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. We will enroll up to 505 couples at the California Family Health Council to have 375 complete both periods. The study will provide data on functional performance, vaginal semen exposure, safety, and acceptability of the two female condoms.
Primary objective: To compare the performance of the PATH Woman's Condom (WC) to the FC2, as assessed by self-reported total clinical failure and its components (clinical breakage, slippage, misdirection, and invagination).
Secondary objectives:
- To compare the ability of the WC and the FC2 to prevent vaginal exposure to semen, as indicated by detection of PSA within the vagina
- To calculate the sensitivity and specificity of reported failures using PSA as the gold standard for the presence of semen
- To compare acceptability of the WC and FC2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Heterosexual couples
- •Mutual monogamy for 3 or more months
- •Both partners are 18 years of age or greater
- •Using effective contraception for more than 3 months, including hormonal methods (oral, injectable, or transdermal), intrauterine device, contraceptive implant, male or female sterilization
- •Agree to remain monogamous for the duration of the study
- •Agree not to wear any genital piercing jewelry while using study condoms
- •Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using a study condom
- •Evidence of general good health without contraindication to sexual activity
- •Couple has vaginal intercourse at least 4 times in a typical month
- •Male partner agrees to ejaculate during intercourse using female condoms
- •Willing and able to participate as required by protocol
排除标准
- •Exclusion criteria for couple (either partner)
- •Intent or desire to become pregnant within 3 months
- •STIs in the past 6 months, including chlamydia, gonorrhea, trichomoniasis, syphilis, or newly acquired HSV
- •Couple routinely uses condoms due to concern for STIs (for more than 90% of sex acts)
- •Known HIV infection
- •At high risk for HIV infection, including having shared injection drug needles or having had sex with someone suspected to have HIV (without having had a negative HIV test since the possible exposure).
- •Allergies to polyurethane or nitrile plastics, or vaginal lubricants (silicone or Astroglide)
- •Recent surgery or biopsy of the male or female genitalia, within the past 60 days including the vulva, vagina, cervix, penis, prostate, vas deferens, or testes
- •Current participation in a study or other research involving a drug, device, or other product. (Participation in an observational study is not exclusionary).
- •Exclusion criteria for female partner
- •Positive pregnancy test
- •Within 2 months of the end of pregnancy
- •Concern for current pregnancy: history of unprotected intercourse since last menses without consistent use of other contraception
- •Use of a contraceptive vaginal ring (Nuvaring)
- •Current use of vaginal products, for treatment of vaginal infection
- •Routine use of diaphragm or vaginal pessary
- •Polycystic ovarian syndrome (oligomenorrhea and hirsutism or prior diagnosis)
- •Distorted vaginal anatomy (e.g. vaginal septum or pelvic prolapse)
- •Exclusion criteria for male partner
- •Difficulty maintaining an erection or achieving ejaculation in the last two months
- •At high risk for HIV infection, including having had anal sex with a man in the last year
- •Prior prostate surgery
- •History of or current prostate cancer
- •Use of medication for a prostate condition
- •Hypospadias or other abnormal penile or male urethral anatomy
结局指标
主要结局
Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination
时间窗: 8 condom uses over up to 3 months
次要结局
- Female condom acceptability(8 condom uses over up to 3 months)
- Vaginal PSA levels(8 condom uses over up to 3 months)