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

HRA Pharma

Status and phase: Completed; Phase 3

Conditions: Emergency Contraception

Treatments: Drug: Use Phase (Ulipristal Acetate, 30 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03208985

151032-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,270 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,270 participants in 1 patient group

Use Phase (Ulipristal Acetate, 30 mg)

Experimental group

Description:

One tablet of 30 mg of ulipristal acetate for emergency contraception

Treatment:

Drug: Use Phase (Ulipristal Acetate, 30 mg)