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 |
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.
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.
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
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