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ContraceptionPhase 4NCT03537768

Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

A Phase 4 study testing Ulipristal Acetate and Levonorgestrel in people with Contraception, run by Kimberly Myer at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Ulipristal Acetate and Levonorgestrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
532 participants
Where
18 sitesUnited States
Study dates
12 Jul 2018to 20 Apr 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
  • Between 18 and 40 years inclusive at the enrollment visit.
  • Weight ≥ 80 kg.
  • Have regular menstrual cycles that typically occur every 21-35 days when not using hormonal contraception.
  • If subject is postpartum or post-abortal, she must have experienced a menstrual bleed since the pregnancy ended
  • If a subject recently used non-injectable hormonal contraception, one bleeding episode consistent with menses must have occurred since last use;
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  • Willing to avoid use of any hormonal or intrauterine contraception until the end of the study;
  • 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);
  • 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;
  • Have a negative urine pregnancy test at time of screening
  • Reports all acts of unprotected coitus since her prior menses are within 72 hours prior to enrollment;
  • Willing to abstain from further acts of unprotected intercourse until the end of the study;
  • 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;
  • Accepts that the risk of pregnancy with oral EC is greater than that following placement of a copper IUD for EC.

Who cannot join

  • Be currently pregnant (positive high-sensitivity urine pregnancy test);
  • Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding;
  • Desire to use hormonal systemic contraception within 5 days of study drug use
  • Have had a female sterilization procedure;
  • Have a partner with a history of vasectomy;
  • Current inability to tolerate oral medication;
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  • Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.
  • Have known liver disease;
  • Have known liver abnormalities with elevated enzymes at least twice the upper limit of normal requiring use of liver enzyme inducers.
  • Have known hypersensitivity to the active substance UPA or LNG, or any of the excipients of the study treatment.
  • Have a current need for exogenous hormones.
  • 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;
  • 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).
  • 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.
  • Have a history of a bariatric surgery procedure associated with malabsorption.
  • Live outside of the catchment area of the study site.
  • Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since using the drug.
  • Be a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. -

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Planned Parenthood League of Massachusetts

    Boston, Massachusetts, 02215

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati-Holmes Hospital

    Cincinnati, Ohio, 45267

  • University Hospitals of Cleveland MacDonald Women's Hospital

    Cleveland, Ohio, 44106

  • University of Colorado

    Denver, Colorado, 80045

  • University of Hawaii

    Honolulu, Hawaii, 96826

  • Essential Access Health

    Los Angeles, California, 30010

  • Bellevue Hospital Center

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh/Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health Science University

    Portland, Oregon, 97239

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • University of California, Davis

    Sacramento, California, 95817

  • University of Utah

    Salt Lake City, Utah, 84106

  • University of California, San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: A Multi-center, Randomized Study of the Efficacy of Ulipristal Acetate (UPA) 30 mg, Levonorgestrel (LNG) 1.5 mg, and LNG 3.0 mg for Emergency Contraception (EC) in Women With Weight ≥ 80 kg

The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse.

Read the detailed description

Orally-dosed emergency contraception (EC) is highly effective when used properly. EC is up to 90% effective at preventing pregnancy following unprotected intercourse. Both ulipristal acetate (UPA) and levonorgestrel (LNG) delay or inhibit ovulation when used for EC. For individual women, use of EC provides a critical backup to prevent unintended pregnancy.

However, obesity may severely impair EC effectiveness. Data from two large randomized control trials to identify risk factors for EC failure. A woman of obese body mass index (BMI) (≥30mg/kg2) using LNG-based EC had more than a 4 times greater risk of pregnancy compared to her normal BMI counterpart and a woman of overweight BMI (25-29.9) was at twice the risk of pregnancy. Failure was also associated with a high body weight. LNG-based EC appears to have a ceiling of efficacy at 70 kg and no efficacy for women 80 kg and above. It is believed that by doubling the dose to LNG 3.0 mg, serum levels of LNG are corrected to a therapeutic range.

Conditions
Contraception
Being tested
Ulipristal Acetate, Levonorgestrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ulipristal AcetateDrug

    Also called Ella

    UPA Tablet

  • LevonorgestrelDrug

    Also called Plan B

    LNG Tablet

  • LevonorgestrelDrug

    Also called Plan B (double dose)

    LNG Tablet (x2)

Study groups in NCT03537768
Study groupRoleWhat they receive
UPA 30mgActive comparatorNot described
Receives: Drug: Ulipristal Acetate
LNG 1.5 mgActive comparatorNot described
Receives: Drug: Levonorgestrel
LNG 3.0Active comparatorNot described
Receives: Drug: Levonorgestrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of pregnancies of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥ 80 kg for emergency contraception (within 72 hours of unprotected intercourse).

    Measured: 1-3 months

Secondary outcomes (1)

  1. Incidence of treatment emergent adverse events of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥80 kg seeking emergency contraception.

    Measured: 1-3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2018
  2. Study start12 Jul 2018
  3. Primary completion20 Apr 2022
  4. Study completion20 Apr 2022

Why it stopped: We weren't seeing as many pregnancies we initially thought.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03537768
Sponsor's protocol ID
CCN013C
Status last verified
Aug 2024
First submitted
17 Apr 2018
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Edelman A, Jensen JT, Brown J, Thomas M, Archer DF, Schreiber CA, Teal S, Westhoff C, Dart C, Blithe DL. Emergency contraception for individuals weighing 80 kg or greater: A randomized trial of 30 mg ulipristal acetate and 1.5 mg or 3.0 mg levonorgestrel. Contraception. 2024 Sep;137:110474. doi: 10.1016/j.contraception.2024.110474. Epub 2024 Apr 23.

    PubMed 38663539

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ulipristal Acetate and Levonorgestrel in people with Contraception, run by Kimberly Myer at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: We weren't seeing as many pregnancies we initially thought.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of pregnancies of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥ 80 kg for emergency contraception (within 72 hours of unprotected intercourse). (time frame: 1-3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537768, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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