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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral LNG + Piroxicam | Experimental | Compare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This ARM will provide participants Oral LNG plus Piroxicam. |
|
| Oral LNG + Placebo | Placebo Comparator | Compare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This Arm will assign participants to oral lng plus a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after consuming study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after consuming study drug |
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Inclusion Criteria:
Exclusion Criteria:
Current pregnancy (+urine pregnancy test in clinic)
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Turok, MD, MPH | Contact | 801-213-2995 | david.turok@hsc.utah.edu | |
| Sarah DeLuca, MPH | Contact | 801-213-2995 | sarah.deluca@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Turok, MD, MPH | University of Utah | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37597523 | Background | Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16. |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D010894 | Piroxicam |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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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.
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| 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. |
|
| 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. | One month after consuming study drug. |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |