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
Raleigh, North Carolina 27603
2218
mi
from 91732
Raleigh, NC
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Albuquerque, New Mexico 87104
648
mi
from 91732
Albuquerque, NM
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Andover, Minnesota 55304
1515
mi
from 91732
Andover, MN
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Belleville, Illinois 62226
1584
mi
from 91732
Belleville, IL
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Boulder, Colorado 80302
812
mi
from 91732
Boulder, CO
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Bremerton, Washington 98310
964
mi
from 91732
Bremerton, WA
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Denver, Colorado 80003
816
mi
from 91732
Denver, CO
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Durham, North Carolina 27704
2205
mi
from 91732
Durham, NC
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Fort Myers, Florida 33919
2203
mi
from 91732
Fort Myers, FL
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Hackensack, New Jersey 07601
2429
mi
from 91732
Hackensack, NJ
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Kansas City, Missouri 64111
1340
mi
from 91732
Kansas City, MO
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Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
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Manchester, Missouri 63088
1556
mi
from 91732
Manchester, MO
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Miami, Florida 33133
2320
mi
from 91732
Miami, FL
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Morristown, New Jersey 07960
2406
mi
from 91732
Morristown, NJ
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New Brunswick, New Jersey 08901
2410
mi
from 91732
New Brunswick, NJ
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New York, New York 10012
2433
mi
from 91732
New York, NY
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Orlando, Florida 32817
2191
mi
from 91732
Orlando, FL
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Pembroke Pines, Florida 33026
2309
mi
from 91732
Pembroke Pines, FL
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Portland, Oregon 97212
829
mi
from 91732
Portland, OR
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Puyallup, Washington 98373
930
mi
from 91732
Puyallup, WA
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Rancho Cucamonga, California 91730
24
mi
from 91732
Rancho Cucamonga, CA
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Saint Louis, Missouri 63108
1570
mi
from 91732
Saint Louis, MO
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Saint Louis Park, Minnesota 55426
1503
mi
from 91732
Saint Louis Park, MN
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Saint Peters, Missouri 63376
1550
mi
from 91732
Saint Peters, MO
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Saint Petersburg, Florida 33701
2130
mi
from 91732
Saint Petersburg, FL
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Seattle, Washington 98122
961
mi
from 91732
Seattle, WA
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Tacoma, Washington 98405
939
mi
from 91732
Tacoma, WA
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Tampa, Florida 33617
2137
mi
from 91732
Tampa, FL
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Trenton, New Jersey 08608
2395
mi
from 91732
Trenton, NJ
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