NCT03208985

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,270 (actual)
• Sponsor: HRA Pharma · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Emergency Contraception

Interventions

Type	Name	Description
DRUG	Use Phase (Ulipristal Acetate, 30 mg)	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).

Timeline

• Start date: 2017-05-23
• Primary completion: 2018-06-14
• Completion: 2018-06-14
• First posted: 2017-07-06
• Last updated: 2022-12-02
• Results posted: 2022-12-02

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study