Clinical trial

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

NCT03208985

Name

151032-001

Description

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.

Trial arms

Trial start

2017-05-23

Estimated PCD

2018-06-14

Trial end

2018-06-14

Status

Completed

Phase

Early phase I

Treatment

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).

Arms:

Use Phase (Ulipristal Acetate, 30 mg)

Size

1270

Primary endpoint

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

Up to 6 Weeks

Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.

Up to 6 Weeks

Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.

Day 1

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1270, 'type': 'ACTUAL'}}

Updated at

2022-12-02

1 organization

1 product

1 indication

Organization

HRA Pharma

Product

Use Phase

Indication

Emergency Contraception