Which Morning-After pill works best for heavier women? study seeks answers

NCT ID NCT03537768

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

532 people

The number who actually took part.

Started

Jul 2018

Finished

Apr 2022

Lead sponsor

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

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Bellevue Hospital Center

    New York, New York, 10016, United States

  • Columbia University

    New York, New York, 10032, United States

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507, United States

  • Essential Access Health

    Los Angeles, California, 30010, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Oregon Health Science University

    Portland, Oregon, 97239, United States

  • Planned Parenthood League of Massachusetts

    Boston, Massachusetts, 02215, United States

  • University Hospitals of Cleveland MacDonald Women's Hospital

    Cleveland, Ohio, 44106, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

  • University of California, San Francisco

    San Francisco, California, 94110, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati-Holmes Hospital

    Cincinnati, Ohio, 45267, United States

  • University of Colorado

    Denver, Colorado, 80045, United States

  • University of Hawaii

    Honolulu, Hawaii, 96826, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh/Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah

    Salt Lake City, Utah, 84106, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

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