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.~Main outcome measures: Percentage of pregnancies prevented (PPP) is the primary outcome measure. Secondary outcome measures include failure rate, rate of occurrence of side effects and pattern of the menstruation following EC.~Data analysis:The percentage of pregnancies prevented, failure rate and rate of occurrence of side effects will be compared between groups using Fisher-Exact test. Continuous variables regarding menstrual pattern between the two groups will be compared by Mann-Whitney U test.~Expected results: LNG plus piroxicam has a higher PPP compared to LNG plus placebo.
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.