Phase 3
N=860
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception
Emergency Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03614494 ↗Enrolled (actual)
860
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Percentage of Pregnancies Prevented — 94.7; 63.3 percentage of pregnancies prevented — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Piroxicam 40 mg (Drug); Levonorgestrel 1.5mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dr. Hang Wun Raymond Li
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Pregnancies Prevented |
94.7; 63.3 | <0.0001 sig |
| SECONDARY Pregnancy Rate |
1; 7 | 0.036 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03614494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.