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

Emergency Contraception Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03208985
Study type Interventional
Source HRA Pharma
Contact
Status Completed
Phase Phase 3
Start date May 23, 2017
Completion date June 14, 2018
View Details
See also
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