Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

• Status: Recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Hang Wun Raymond Li
• Collaborator: The Family Planning Association of Hong Kong
• Treatments: Levonorgestrel; Piroxicam

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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