Levonorgestrel-piroxicam Combination Versus Ulipristal Acetate for Emergency Contraception: a Randomised Double-blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
The goal of this clinical trial is to compare the failure rate of the levonorgestrel (LNG)-piroxicam combination regimen versus ulipristal acetate (UPA) as emergency contraception (EC). The main questions it aims to answer are:
- whether the LNG-piroxicam combination regimen has a lower failure rate than UPA for EC;
- whether the LNG-piroxicam combination regimen has a higher percentage of pregnancies prevented than UPA for EC
- whether there is any difference in the change in the subsequent menstrual cycle and adverse effect profile between the two regimens
Participants will:
- Take a single dose of either (i) LNG 1.5 mg plus piroxicam 40 mg and a placebo tablet resembling UPA, or (ii) UPA 30 mg plus placebo tablets resembling LNG and piroxicam.
- Have a blood test for serum LH, oestradiol an progesterone.
- Keep a diary of their vaginal bleeding episodes, adverse effects symptoms, any further acts of intercourse and the type of contraception used.
- Have a follow-up either in person by phone about 1-2 weeks after the next expected menstruation.
- If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out.
详细描述
Participating women will be randomised to either the LNG-piroxicam group or UPA group in 1:1 ratio according to a computer-generated randomisation list in varying blocks. Serially numbered vouchers bearing the drug code in sealed envelopes will be prepared, according to which the study medication will be prepacked by another research nurse not directly involved in patient contact in this study. The subjects, clinicians and research staff with patient contact will be blinded to the group assignment. The codes for the treatment groups will only be revealed to the investigators after completion of the whole study and statistical analyses.
Baseline assessment of subjects:
- Medical and menstrual history will be taken.
- Measurement of body height, weight and blood pressure.
- Pregnancy test
- Measurement of serum LH, oestradiol and progesterone to classify the subject as pre-ovulatory versus post-ovulatory. The serum hormonal levels will be used to estimate the phase of the menstrual cycle at the time of presentation in relation to the day of ovulation.
Treatment:
The recruited subjects will receive the assigned study medications under direct supervision. Those in the LNG-piroxicam group will receive piroxicam 40 mg, LNG 1.5 mg and a placebo pill resembling UPA. Those in the UPA group will receive UPA 30 mg and placebo pills resembling LNG and piroxicam respectively. They will be given a diary chart to record vaginal spotting and bleeding, possible side effects and further acts of intercourse, if any, and the contraceptive method used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 18-45 years;
- •requesting an oral EC within 120 hours of a single or the first act of unprotected intercourse in the current menstrual cycle;
- •available for follow-up over the next 6 weeks.
排除标准
- •post-abortion or postpartum and period have not yet returned,
- •being on the following drugs currently: anticoagulants, cyclosporine, tacrolimus, corticosteroids, lithium, serotonin reuptake inhibitors (SSRIs), quinolones
- •having unprotected intercourse in this cycle more than 120 hours before attending the clinic,
- •being found pregnant at the time of presentation,
- •breastfeeding,
- •having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,
- •uncertain about the date of the last menstrual period,
- •having used a hormonal contraceptive (including EC), progestogen-containing medication or NSAID in the recent one week,
- •having history of asthma, urticaria or other allergic reactions to piroxicam, aspirin or other NSAIDs,
- •having history of ischaemic heart disease, heart failure, hypertension, cerebrovascular disease or kidney failure requiring dialysis
- •having history of peptic ulcer disease and/or gastrointestinal bleeding.
研究组 & 干预措施
LNG-piroxicam
Levonorgestrel-piroxicam combination
干预措施: Levonorgestrel (Drug)
UPA
Ulipristal only
干预措施: Placebo - LNG (Drug)
UPA
Ulipristal only
干预措施: Placebo - Piroxicam (Drug)
LNG-piroxicam
Levonorgestrel-piroxicam combination
干预措施: Placebo - UPA (Drug)
LNG-piroxicam
Levonorgestrel-piroxicam combination
干预措施: Piroxicam (Drug)
UPA
Ulipristal only
干预措施: Ulipristal Acetate (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: 1 month
Percentage of women having positive hCG test within one month
次要结局
- Change in bleeding pattern(1 month)
- Percentage of pregnancies prevented(1 month)
- Adverse effects(1 month)