Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age16-35
SponsorUniversity of Utah
About this trial
This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.
Eligibility criteria
Qualifiers
Between 16-35 years old and desire LNG for EC
Unprotected intercourse within 72 hours
Biologically capable of pregnancy
Regular menstrual cycle 21-35 days long with known LMP +/- 3 days
Disqualifiers
Current pregnancy (+urine pregnancy test in clinic)
Breastfeeding, post abortion or postpartum without resuming menstruation
Use of hormonal contraception (including oral EC) within seven days of enrollment
Use of NSAIDs (ibuprofen, naproxen, celecoxib, diclofenac, aspirin) in the prior week
Trial design
Treatments tested in this trial
- Levonorgestrel 1.5 mg and Piroxicam 40 mg
- Oral LNG + Placebo
Treatment groups
1,458 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov