Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,458
- 主要终点
- EC efficacy between the two study groups measured by pregnancy status four weeks after EC use.
研究概览
简要总结
This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 16-35 years old and desire LNG for EC
- •Unprotected intercourse within 72 hours
- •Biologically capable of pregnancy
- •Regular menstrual cycle 21-35 days long with known LMP +/- 3 days
- •Working cell phone number that receives text messages (for Aim 3 participants phone with capability to download and use the Oova application and submit data)
- •Fluent in English and/or Spanish
- •Willing to comply with the study requirements including 1-month urine pregnancy test
- •No known contraindications to oral LNG or piroxicam - For secondary outcome assessing pregnancy risk for participants receiving study drug on day of ovulation or later - are currently using a menstrual cycle tracking application and can demonstrate according to the application that they are on the day of ovulation or post ovulation.
排除标准
- •Current pregnancy (+urine pregnancy test in clinic)
- •Breastfeeding, post abortion or postpartum without resuming menstruation
- •Use of hormonal contraception (including oral EC) within seven days of enrollment
- •Use of NSAIDs (ibuprofen, naproxen, celecoxib, diclofenac, aspirin) in the prior week
- •Highly effective contraception including permanent contraception (including partner with vasectomy), IUD, or contraceptive implant
- •Allergy to LNG or piroxicam
- •Desires UPA for EC
- •History of stroke, myocardia infarction, ischemic heart disease, uncontrolled hypertension, congestive heart failure, peptic ulcer disease, renal or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.
研究组 & 干预措施
Oral LNG + Piroxicam
Compare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This ARM will provide participants Oral LNG plus Piroxicam.
干预措施: Levonorgestrel 1.5 mg and Piroxicam 40 mg (Drug)
Oral LNG + Placebo
Compare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This Arm will assign participants to oral lng plus a placebo.
干预措施: Oral LNG + Placebo (Drug)
结局指标
主要结局
EC efficacy between the two study groups measured by pregnancy status four weeks after EC use.
时间窗: One month after consuming study drug
The study's primary outcome is a confirmed pregnancy at four weeks (+/- 5 days) after EC study drug consumption as determined by a positive high sensitivity urine pregnancy test or clinical documentation of a pregnancy at any time that dates back to a fertilization date that is within 5 days of EC study drug consumption.
次要结局
- Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups.(One month after consuming study drug)
- Test hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.(One month after consuming study drug.)