On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- ovulatory disruption
研究概览
简要总结
This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility.
详细描述
This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility. We will compare the proportion of women with ovulatory disruption after taking the study medications with those women's own placebo cycles and also to previously established/published rates of ovulatory disruption of ulipristal alone.9 Given the established efficacy of ulipristal during the follicular time period as well as the theoretical mechanism of meloxicam to disrupt cumulus-oocyte expansion is a late step in ovulation, we hypothesize that this medication could emerge as the best candidate for an oral on-demand contraceptive option.
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
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, aged 18-38
- •English speaking
- •Able to consent, literate
- •Access to smart phone throughout study
- •History of regular menses
- •Documented baseline cycle with ovulation
- •Not currently using or needing hormonal contraception
- •Not currently using or needing regular NSAIDS
- •Able to commit to frequency of study visits
排除标准
- •Currently or recently (<2months) pregnant
- •Currently or recent (<2months) breastfeeding
- •Current or recent (<2months) use of hormonal medication
- •Regular NSAID use
- •Known cardiac risk factors (e.g. personal history of obesity, HTN, cardiac disease, diabetes)
- •BMI > 30, as some studies have shown decreased efficacy of ulipristal in obese women37
- •Allergy or previous unacceptable side effects with study medications
研究组 & 干预措施
Ulipristal 30mg plus Meloxicam 15mg
Each study participant will complete one menstrual cycle without medication. Her second menstrual cycle, each study participant will receive ulipristal acetate plus meloxicam at peak fertility.
干预措施: Ulipristal Acetate 30 MG Oral Tablet (Drug)
结局指标
主要结局
ovulatory disruption
时间窗: 8 weeks from start of study, approximately
(1) no follicle rupture or (2) follicle rupture that was (a) not preceded within 24-48 hours by an LH peak, (b) preceded by a blunted LH peak (\<21IU/L), and/or (c) followed by a luteal phase progesterone peak of \<3ng/mL
次要结局
- progesterone hormone levels(8 weeks from start of study, approximately)
- luteal hormone levels(8 weeks from start of study, approximately)
- maximum follicle diameter(8 weeks from start of study, approximately)
研究者
Erica Cahill
Clinical Instructor
Stanford University