Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 860
- 试验地点
- 2
- 主要终点
- Percentage of Pregnancies Prevented
研究概览
简要总结
This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Efficacy will be measured as the percentage of pregnancies prevented.
详细描述
Objective: To compare the percentage of pregnancies prevented by LNG co-administered with piroxicam or placebo for oral emergency contraception (EC) by a randomised controlled trial.
Hypothesis to be tested: LNG plus piroxicam has higher percentage of pregnancies prevented compared with LNG plus placebo for oral emergency contraception.
Design and subjects: This will be a prospective, randomised placebo-controlled clinical trial. Women attending the Family Planning Association of Hong Kong for oral EC within 72 hours of unprotected sexual intercourse will be recruited.
Study instruments: Prospective follow-up of subjects in the clinic for the primary and secondary outcomes.
Interventions: Eligible subjects will be randomised to receive one of the two treatment regimens, i.e. Group A: a single dose of LNG 1.5 mg and piroxicam 40 mg, or Group B: a single dose of LNG 1.5mg and placebo under direct supervision.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women aged 18 years or above;
- •requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle;
- •having menstrual cycles between 24 and 42 days
- •willing to abstain from further acts of unprotected intercourse and;
- •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 prescription drugs currently
- •having unprotected intercourse in this cycle more than 72 hours or more than once 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 hormonal contraceptive (including EC pill) or NSAID in the current or past one cycle,
- •having history of asthma, urticarial or other allergic reactions to piroxicam, aspirin or other NSAIDs,
- •having history of ischaemic heart disease in the past one year
- •having history of pelvic ulcer disease and/or gastrointestinal bleeding
研究组 & 干预措施
Placebo
Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose
干预措施: Levonorgestrel 1.5mg (Drug)
Piroxicam
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
干预措施: Piroxicam 40 mg (Drug)
Piroxicam
Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose
干预措施: Levonorgestrel 1.5mg (Drug)
结局指标
主要结局
Percentage of Pregnancies Prevented
时间窗: 1 month
(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).
次要结局
- Pregnancy Rate(1 month)
研究者
Dr. Hang Wun Raymond Li
Clinical Associate Professor
The University of Hong Kong