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

Sponsor
Health Decisions (Other)
Overall Status
Unknown status
CT.gov ID
NCT03537768
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
1,200
Enrollment
18
Locations
3
Arms
26.6
Anticipated Duration (Months)
66.7
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 12, 2018
Anticipated Primary Completion Date :
Jul 31, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: UPA 30mg

Drug: Ulipristal Acetate
UPA Tablet
Other Names:
  • Ella

    		•
    Active Comparator: LNG 1.5 mg

    Drug: Levonorgestrel
    LNG Tablet
    Other Names:
  • Plan B

    		•
    Active Comparator: LNG 3.0

    Drug: Levonorgestrel
    LNG Tablet (x2)
    Other Names:
  • Plan B (double dose)

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Essential Access Health Los Angeles California United States 30010
    2 University of California, Davis Sacramento California United States 95817
    3 University of California, San Francisco San Francisco California United States 94110
    4 University of Colorado Denver Colorado United States 80045
    5 University of Hawaii Honolulu Hawaii United States 96826
    6 University of Chicago Chicago Illinois United States 60637
    7 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224
    8 Planned Parenthood League of Massachusetts Boston Massachusetts United States 02215
    9 Bellevue Hospital Center New York New York United States 10016
    10 Columbia University New York New York United States 10032
    11 University of Cincinnati-Holmes Hospital Cincinnati Ohio United States 45267
    12 University Hospitals of Cleveland MacDonald Women's Hospital Cleveland Ohio United States 44106
    13 Oregon Health Science University Portland Oregon United States 97239
    14 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    15 University of Pittsburgh/Magee Women's Hospital Pittsburgh Pennsylvania United States 15213
    16 Women & Infants Hospital of Rhode Island Providence Rhode Island United States 02905
    17 University of Utah Salt Lake City Utah United States 84106
    18 Eastern Virginia Medical School Norfolk Virginia United States 23507

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Diana Blithe, PhD, NICHD Director

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Health Decisions
    ClinicalTrials.gov Identifier:
    NCT03537768
    Other Study ID Numbers:
    • CCN013C
    First Posted:
    May 25, 2018
    Last Update Posted:
    Oct 8, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Emergencies
    Levonorgestrel
    Ulipristal acetate

    Study Results

    No Results Posted as of Oct 8, 2019