A Phase 3, Multicenter, Open-Label, Single-Arm Study of MR-130A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,630
- 试验地点
- 100
- 主要终点
- To determine the contraceptive efficacy of progestin only patch when used over 13 cycles
研究概览
简要总结
The Sponsor is developing a progestin-only contraceptive transdermal system (patch).
The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated.
The study patch is a transdermal system that contains the active ingredient, progestin.
详细描述
Unintended pregnancy continues to be a significant reproductive health problem worldwide. Although the increase in the availability of longer-acting contraceptive methods has improved the situation, the continuing development of newer safe and effective contraception is crucial for women's health.
The development of a progestin-only contraceptive with more convenient dosing may provide women with additional options. The investigational patch is intended to provide an option for women who may not be able to use estrogen-containing combined hormonal contraceptives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age.
- •Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year.
- •Has negative UPT results at screening and at enrollment visits.
- •Has normal, regular menstrual cycles that are between 21 and 35 days in duration over the last 6 months.
- •Engages in regular heterosexual vaginal intercourse (at least once per cycle), with a partner who is not known to be sub fertile or infertile.
- •Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study.
- •Able to understand and voluntarily provide written informed consent or assent (if the participant is adolescent prior to undergoing any trial related procedure) to participate in the study.
排除标准
- •Known or suspected pregnancy or planning pregnancy during next 12 months.
- •Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch.
- •History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.
- •Known infertility (current or known history) or history of sterilization in either partner.
- •Received injectable hormonal contraceptive therapy within 10 months of study enrollment.
- •Current use of hormonal contraceptive implants.
- •Has non-hormonal or hormonal intrauterine device (IUD) in place; or has had a recent IUD removal without one spontaneous menses after removal prior to the date of enrollment.
- •Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal or cesarean delivery.
- •Participants lactating at the time of screening into the study or has occurrence of less than 3 regular menstrual cycles after cessation of lactation.
- •Anticipates routine use of condoms or any other form of back-up contraception for protection from sexually transmitted infections during the study or for emergency contraception.
- •Participants having a known contraindication to progestin-only contraception.
- •Known or suspected progestin sensitive malignant or premalignant conditions including but not limited to carcinoma of endometrium, ovary, or fallopian tubes.
- •Skin abnormality (e.g., tattoo or scar) at all possible application sites.
- •Long-term treatment with drugs or herbal products that are moderate/strong inducers or inhibitors of CYP3A
- •Has uncontrolled thyroid disorder (thyrotoxicosis or myxedema).
- •Has diagnosis of hereditary angioedema.
- •Participants with abnormal significant liver function tests as measured by liver function tests
- •Has a significantly abnormal cervical cancer screening test.
- •Participants with chlamydial or gonorrheal infection at screening.
- •Has unexplained vaginal bleeding within the past 6 months or any abnormal bleeding which is expected to recur during the study.
研究组 & 干预措施
This is a single-arm study.
The study patch is a transdermal system that contains the active ingredient progestin.
This study is an open-label, single-arm study. This means that all participants in the study will receive the study patch
干预措施: Transdermal system containing progestin (Drug)
结局指标
主要结局
To determine the contraceptive efficacy of progestin only patch when used over 13 cycles
时间窗: 13 cycles [of 4 weeks (28 days)
The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years.
次要结局
- To determine the efficacy in obese population (Body mass index (BMI) ≥30.0 kg/m2)(13 cycles [of 4 weeks (28 days))
- To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2)(13 cycles [of 4 weeks (28 days))
- Cycle-wise and cumulative pregnancy rates over 1 year(13 cycles [of 4 weeks (28 days))
- Method failure PI(13 cycles [of 4 weeks (28 days))
- Incidence of adverse events and serious adverse events(13 cycles [of 4 weeks (28 days))
- Incidence of application site reactions(13 cycles [of 4 weeks (28 days))
- Unscheduled bleeding(13 cycles [of 4 weeks (28 days))
- Adhesion performance(13 cycles [of 4 weeks (28 days))
- progestin plasma concentrations(5 cycles [of 4 weeks (28 days))