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

NCT ID: NCT03537768

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2022-04-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

UPA 30mg

Group Type: ACTIVE_COMPARATOR

Ulipristal Acetate

Intervention Type: DRUG

UPA Tablet

LNG 1.5 mg

Group Type: ACTIVE_COMPARATOR

Levonorgestrel

Intervention Type: DRUG

LNG Tablet

LNG 3.0

Group Type: ACTIVE_COMPARATOR

Levonorgestrel

Intervention Type: DRUG

LNG Tablet (x2)

Interventions

Ulipristal Acetate

UPA Tablet

Intervention Type: DRUG

Levonorgestrel

LNG Tablet

Intervention Type: DRUG

Levonorgestrel

LNG Tablet (x2)

Intervention Type: DRUG

Other Intervention Names

Ella; Plan B; Plan B (double dose)

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Kimberly Myer

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Myer

Program Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diana Blithe, PhD

Role: STUDY_DIRECTOR

NICHD Director

Locations

Essential Access Health

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado

Denver, Colorado, United States

University of Hawaii

Honolulu, Hawaii, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Planned Parenthood League of Massachusetts

Boston, Massachusetts, United States

Bellevue Hospital Center

New York, New York, United States

Columbia University

New York, New York, United States

University of Cincinnati-Holmes Hospital

Cincinnati, Ohio, United States

University Hospitals of Cleveland MacDonald Women's Hospital

Cleveland, Ohio, United States

Oregon Health Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh/Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

University of Utah

Salt Lake City, Utah, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38663539 (View on PubMed)

Other Identifiers

CCN013C

Identifier Type: -

Identifier Source: org_study_id