Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial

UW18-003

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.

2018-08-20

2022-10-05

2022-10-05

Completed

Early phase I

860

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 860, 'type': 'ACTUAL'}}

2024-05-06