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Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

ConditionsEmergency ContraceptionContraceptionCOX-2 Inhibitor
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Levonorgestrel 1.5 mg and Piroxicam 40 mg

    Drug

    The study intervention is a combination of Levonorgestrel 1.5 mg and Piroxicam 40 mg for emergency contraception. Participants will be randomized 3:1 to this vs. Levonorgestrel 1.5 mg and placebo.

  • Oral LNG + Placebo

    Drug

    The study intervention is a combination of Levonorgestrel 1.5 mg and placebo for emergency contraception. Participants will be randomized 3:1 to Levonorgestrel 1.5 mg and Piroxicam vs. this option.

Treatment groups

1,458 Participants
are divided into 2 treatment groups
Group A: Oral LNG + PiroxicamExperimental treatment 1 intervention
Group B: Oral LNG + PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

EC efficacy between the two study groups measured by pregnancy status four weeks after EC use.

The study's primary outcome is a confirmed pregnancy at four weeks (+/- 5 days) after EC study drug consumption as determined by a positive high sensitivity urine pregnancy test or clinical documentation of a pregnancy at any time that dates back to a fertilization date that is within 5 days of EC study drug consumption.

Time frame
One month after consuming study drug

Secondary outcomes

1

Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups.

The primary outcome for this aim will be the pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups. We will compare the pregnancy risk among the subset of participants weighing ≥75 kg randomized to LNG + piroxicam vs. LNG + placebo.

Time frame
One month after consuming study drug
2

Test hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.

Aim 3 statistical analyses will use superiority design to test the hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.

Time frame
One month after consuming study drug.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: