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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:8/8/2018
Start Date:May 23, 2017
End Date:June 14, 2018

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A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

- Cannot read, speak and understand English

- Cannot see well enough to read information on the label
We found this trial at
30
sites
Tacoma, Washington 98405
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Tacoma, WA
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Albuquerque, New Mexico 87104
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Albuquerque, NM
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Andover, Minnesota 55304
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Andover, MN
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Belleville, Illinois 62226
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Belleville, IL
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Boulder, Colorado 80302
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Boulder, CO
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Bremerton, Washington 98310
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Bremerton, WA
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Denver, Colorado 80003
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Denver, CO
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Durham, North Carolina 27704
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Durham, NC
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Fort Myers, Florida 33919
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Fort Myers, FL
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Hackensack, New Jersey 07601
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Hackensack, NJ
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Kansas City, Missouri 64111
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Kansas City, MO
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Manchester, Missouri 63088
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Manchester, MO
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Miami, Florida 33133
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Miami, FL
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Morristown, New Jersey 07960
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Morristown, NJ
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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New York, New York 10012
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New York, NY
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Orlando, Florida 32817
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Orlando, FL
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Pembroke Pines, Florida 33026
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Pembroke Pines, FL
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Portland, Oregon 97212
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Portland, OR
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Puyallup, Washington 98373
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Puyallup, WA
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Raleigh, North Carolina 27603
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Raleigh, NC
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Rancho Cucamonga, California 91730
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Rancho Cucamonga, CA
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Saint Louis, Missouri 63108
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Saint Louis, MO
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Saint Louis Park, Minnesota 55426
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Saint Louis Park, MN
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Saint Peters, Missouri 63376
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Saint Peters, MO
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Saint Petersburg, Florida 33701
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Saint Petersburg, FL
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Seattle, Washington 98122
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Seattle, WA
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Tampa, Florida 33617
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Tampa, FL
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Trenton, New Jersey 08608
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Trenton, NJ
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