Which Morning-After pill works best for heavier women? study seeks answers
NCT ID NCT03537768
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared three emergency contraceptive pills (ulipristal acetate 30 mg, levonorgestrel 1.5 mg, and levonorgestrel 3.0 mg) in women weighing 80 kg or more who had unprotected sex within the last 72 hours. The goal was to see which pill prevents pregnancy most effectively in this group. The study was terminated early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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532 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Apr 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care. 2. Between 18 and 40 years inclusive at the enrollment visit. 3. Weight ≥ 80 kg. 4. Have regular menstrual cycles that typically occur every 21-35 days when not using hormonal contraception. 5. If subject is postpartum or post-abortal, she must have experienced a menstrual bleed since the pregnancy ended 6. If a subject recently used non-injectable hormonal contraception, one bleeding episode consistent with menses must have occurred since last use; 7. Willing to avoid use of any hormonal or intrauterine contraception until the end of the study; 8. For women with a recent history of Depo Provera use, the most recent injection must have been at least 6 months before study entry, and the subject must have had at least one normal menstrual cycle (2 consecutive menses); 9. Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, condom breakage (including condoms lubricated with spermicide), or other barrier contraceptive method failure; 10. Have a negative urine pregnancy test at time of screening 11. Reports all acts of unprotected coitus since her prior menses are within 72 hours prior to enrollment; 12. Willing to abstain from further acts of unprotected intercourse until the end of the study; 13. Give voluntary, written informed consent, and agree to observe all study requirements including being available for follow up for at least the next 4 weeks; 14. Accepts that the risk of pregnancy with oral EC is greater than that following placement of a copper IUD for EC. Exclusion Criteria: 1. Be currently pregnant (positive high-sensitivity urine pregnancy test); 2. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding; 3. Desire to use hormonal systemic contraception within 5 days of study drug use 4. Have had a female sterilization procedure; 5. Have a partner with a history of vasectomy; 6. Current inability to tolerate oral medication; 7. Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year. 8. Have known liver disease; 9. Have known liver abnormalities with elevated enzymes at least twice the upper limit of normal requiring use of liver enzyme inducers. 10. Have known hypersensitivity to the active substance UPA or LNG, or any of the excipients of the study treatment. 11. Have a current need for exogenous hormones. 12. Have concomitant use of strong CYP3A4 inhibitors (as identified by the FDA) or inducers at the time of or planned use within 3 days of dosing; 13. Use any medications that can interfere with the metabolism of hormonal contraceptives; take antibiotics that can interfere with metabolism of hormonal contraceptives at the time of or planned use within 3 days of dosing of the study drug; or use any drugs designated by the FDA as falling in the Pregnancy and Lactation narrative subsections (formerly Category D or X medications). 14. Current or recent (within one month) participation in any other trial of an investigational medicine or device or planning to participate in another clinical trial during this study. 15. Have a history of a bariatric surgery procedure associated with malabsorption. 16. Live outside of the catchment area of the study site. 17. Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since using the drug. 18. Be a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. -
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bellevue Hospital Center
New York, New York, 10016, United States
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Columbia University
New York, New York, 10032, United States
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Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
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Essential Access Health
Los Angeles, California, 30010, United States
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Oregon Health Science University
Portland, Oregon, 97239, United States
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Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215, United States
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University Hospitals of Cleveland MacDonald Women's Hospital
Cleveland, Ohio, 44106, United States
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University of California, Davis
Sacramento, California, 95817, United States
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University of California, San Francisco
San Francisco, California, 94110, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Cincinnati-Holmes Hospital
Cincinnati, Ohio, 45267, United States
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University of Colorado
Denver, Colorado, 80045, United States
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University of Hawaii
Honolulu, Hawaii, 96826, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh/Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
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University of Utah
Salt Lake City, Utah, 84106, United States
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Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
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