Contraception, COX-2 Inhibitor, Emergency Contraception
Conditions
Keywords
Emergency Contraception, Piroxicam, Contraception
Brief summary
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.
Interventions
DRUGLevonorgestrel 1.5 mg and Piroxicam 40 mg
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.
DRUGOral LNG + Placebo
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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A recent study in Hong Kong tested a combination of levonorgestrel and piroxicam pills for emergency contraception and found a pregnancy rate of 0.2%, an order of magnitude more effective than the most commonly used U.S. method of emergency contraception, levonorgestrel alone. 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
Sex/Gender
FEMALE
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Working cell phone number that receives text messages (for Aim 3 participants phone with capability to download and use the Oova application and submit data) * Fluent in English and/or Spanish * Willing to comply with the study requirements including 1-month urine pregnancy test * No known contraindications to oral LNG or piroxicam - For secondary outcome assessing pregnancy risk for participants receiving study drug on day of ovulation or later - are currently using a menstrual cycle tracking application and can demonstrate according to the application that they are on the day of ovulation or post ovulation.
Exclusion criteria
* 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 * Highly effective contraception including permanent contraception (including partner with vasectomy), IUD, or contraceptive implant * Allergy to LNG or piroxicam * Desires UPA for EC History of stroke, myocardia infarction, ischemic heart disease, uncontrolled hypertension, congestive heart failure, peptic ulcer disease, renal or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EC efficacy between the two study groups measured by pregnancy status four weeks after EC use. | One month after consuming study drug | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups. | One month after consuming study drug | 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. |
| 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. | One month after consuming study drug. | 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. |
Contacts
CONTACTDavid Turok, MD, MPH
CONTACTSarah DeLuca, MPH
PRINCIPAL_INVESTIGATORDavid Turok, MD, MPH
University of Utah
Outcome results
None listed