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

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.

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Key information

Conditions

Emergency Contraception

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

HRA Pharma Investigational Site, Rancho Cucamonga, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use Phase (Ulipristal Acetate, 30 mg)

Drug

All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate.

Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).

Primary outcomes

Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.

Time frame: Up to 6 Weeks

The first primary endpoint is the proportion in which the denominator includes all dosing instances of the IP and the numerator includes all dosing instances of the IP which were taken within 120 hours (5 days) of the subject's most recent episode of unprotected sex.
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.

Time frame: Up to 6 Weeks

The second primary endpoint is the proportion in which the denominator is all discrete dosing instances of the IP and the numerator includes all dosing instances where no more than one tablet was taken.
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.

Time frame: Day 1

The third primary endpoint is the proportion in which the denominator includes all females who selected to use the product (regardless of whether they purchased/used) and the numerator includes all female selectors who were not pregnant at the time of the selection decision.

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study title

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

Acronym: LIBRella

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jul 6, 2017
Registry last updated: Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed