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

October 7, 2019 updated by: Health Decisions

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 30010
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Principal Investigator:
          • Mitchell Creinin
        • Contact:
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Philip Darney, MD
    • Colorado
      • Denver, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado
        • Contact:
        • Principal Investigator:
          • Stephanie Teal, MD
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • University of Hawaii
        • Contact:
        • Principal Investigator:
          • Bliss Kaneshiro, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago
        • Contact:
          • Sadia Haider
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Not yet recruiting
        • Johns Hopkins Bayview Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne Burke
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Planned Parenthood League of Massachusetts
        • Contact:
        • Principal Investigator:
          • Alisa Goldberg, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Bellevue Hospital Center
        • Contact:
        • Principal Investigator:
          • Treasure Walker
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carolyn Westhoff
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati-Holmes Hospital
        • Contact:
        • Principal Investigator:
          • MIchael Thomas, MD
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals of Cleveland MacDonald Women's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • James H. Liu, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Science University
        • Contact:
        • Principal Investigator:
          • Alison Edelman
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh/Magee Women's Hospital
        • Principal Investigator:
          • Beatrice Chen, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Not yet recruiting
        • Women & Infants Hospital of Rhode Island
        • Contact:
          • Rebecca Allen
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Not yet recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • David Turok, MD
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Eastern Virginia Medical School
        • Principal Investigator:
          • David Archer
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Drug: Levonorgestrel
LNG Tablet (x2)
Other Names:
  • Plan B (double dose)
Active Comparator: LNG 3.0
Drug: Levonorgestrel
LNG Tablet
Other Names:
  • Plan B
Drug: Levonorgestrel
LNG Tablet (x2)
Other Names:
  • Plan B (double dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 1-3 months
1-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Decisions

Collaborators

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

Investigators

  • Study Director: Diana Blithe, PhD, NICHD Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2018

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCN013C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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