A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions

Last updated: November 16, 2022
Sponsor: HRA Pharma
Overall Status: Completed

Phase

3

Condition

Birth Control

Contraception

Treatment

Use Phase (Ulipristal Acetate, 30 mg)

Clinical Study ID

NCT03208985
151032-001
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women who are self-pay or who are willing to be self-pay for the purposes of the studyand who present for emergency contraception only for their own use

Exclusion

Exclusion Criteria:

  • Cannot read, speak and understand English
  • Cannot see well enough to read information on the label

Study Design

Total Participants: 1270
Treatment Group(s): 1
Primary Treatment: Use Phase (Ulipristal Acetate, 30 mg)
Phase: 3
Study Start date:
May 23, 2017
Estimated Completion Date:
June 14, 2018

Study Description

All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.

Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.

Connect with a study center

  • HRA Pharma Investigational Site

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Boulder, Colorado 80302
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Denver, Colorado 80207
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Fort Myers, Florida 33919
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Miami, Florida 33133
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Orlando, Florida 32817
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Tampa, Florida 33617
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Belleville, Illinois 62226
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Andover, Minnesota 55304
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Saint Louis Park, Minnesota 55426
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Manchester, Missouri 63088
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Trenton, New Jersey 08608
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Albuquerque, New Mexico 87104
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    New York, New York 10012
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Durham, North Carolina 27704
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Raleigh, North Carolina 27603
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Portland, Oregon 97212
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Bremerton, Washington 98310
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Puyallup, Washington 98373
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Seattle, Washington 98133
    United States

    Site Not Available

  • HRA Pharma Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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