Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Delay in follicular rupture
研究概览
简要总结
The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.
详细描述
Each of us can respond differently to a drug or medication based on our genetics. An emergency contraceptive, ulipristal acetate or UPA, normally works by stopping or delaying the ovary from releasing an egg (ovulation). Our bodies break down UPA in order to use it through a system call the cytochrome P450 pathway but this pathway can be faster or slower depending on our genetics. The investigators want to learn more about how our individual genetic differences in this pathway change how the ovary responds to UPA. The overall goal of this research is to improve the effectiveness of emergency contraception for all people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Generally healthy women
- •Aged 18-40
- •regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng/mL or greater during the luteal phase of the screening cycle.
排除标准
- •Pregnant, seeking pregnancy, or breastfeeding
- •Known allergy to study medication
- •Recent use of hormonal contraception
- •Irregular periods (<21 days or >35 day cycles)
- •Routine use of nonsteroidal anti-inflammatory drugs
- •Metabolic disorders
- •Any condition that would preclude the provision of informed consent
- •Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be CYP3A4 inducers, inhibitors, or CYP3A drug substrates
研究组 & 干预措施
Active CYP3A5 Allele
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles
干预措施: Ulipristal acetate (Drug)
Inactive CYP3A5 Allele
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles
干预措施: Ulipristal acetate (Drug)
结局指标
主要结局
Delay in follicular rupture
时间窗: over 1 menstrual cycle (assessed up to approximately 30 days)
Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or \>50% reduction in size of the leading follicle
Concentration of UPA
时间窗: 5 days after taking study drug
mean concentration maximum (Cmax) for UPA
次要结局
未报告次要终点
研究者
Alison Edelman
Professor, OB/GYN
Oregon Health and Science University