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

NCT03537768 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: CCN013C
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (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).

  1-3 months

Secondary Outcomes (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.

  1-3 months

Study Arms (3)

UPA 30mg

ACTIVE COMPARATOR

Drug: Ulipristal Acetate

LNG 1.5 mg

ACTIVE COMPARATOR

Drug: Levonorgestrel

LNG 3.0

ACTIVE COMPARATOR

Drug: Levonorgestrel

Interventions

Ulipristal Acetate DRUG

UPA Tablet

Also known as: Ella

UPA 30mg

Levonorgestrel DRUG

LNG Tablet

Also known as: Plan B

LNG 1.5 mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Kimberly Myer: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (18)

Essential Access Health

Los Angeles, California, 30010, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Hawaii

Honolulu, Hawaii, 96826, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati-Holmes Hospital

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland MacDonald Women's Hospital

Cleveland, Ohio, 44106, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh/Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Utah

Salt Lake City, Utah, 84106, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 38663539 DERIVED

MeSH Terms

Interventions

ulipristal acetate; Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Diana Blithe, PhD

  NICHD Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 25, 2018
• Study Start: July 12, 2018
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: November 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)