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

Emergency Contraception Clinical Trial

— LIBRella  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208985
• Other study ID #: 151032-001
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: November 2022
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1270
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Contraception

Intervention

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).

Locations

Country	Name	City	State
United States	HRA Pharma Investigational Site	Albuquerque	New Mexico
United States	HRA Pharma Investigational Site	Albuquerque	New Mexico
United States	HRA Pharma Investigational Site	Andover	Minnesota
United States	HRA Pharma Investigational Site	Belleville	Illinois
United States	HRA Pharma Investigational Site	Boulder	Colorado
United States	HRA Pharma Investigational Site	Bremerton	Washington
United States	HRA Pharma Investigational Site	Denver	Colorado
United States	HRA Pharma Investigational Site	Denver	Colorado
United States	HRA Pharma Investigational Site	Durham	North Carolina
United States	HRA Pharma Investigational Site	Fort Myers	Florida
United States	HRA Pharma Investigational Site	Hackensack	New Jersey
United States	HRA Pharma Investigational Site	Kansas City	Missouri
United States	HRA Pharma Investigational Site	Las Vegas	Nevada
United States	HRA Pharma Investigational Site	Manchester	Missouri
United States	HRA Pharma Investigational Site	Miami	Florida
United States	HRA Pharma Investigational Site	Morristown	New Jersey
United States	HRA Pharma Investigational Site	New Brunswick	New Jersey
United States	HRA Pharma Investigational Site	New York	New York
United States	HRA Pharma Investigational Site	Orlando	Florida
United States	HRA Pharma Investigational Site	Pembroke Pines	Florida
United States	HRA Pharma Investigational Site	Portland	Oregon
United States	HRA Pharma Investigational Site	Puyallup	Washington
United States	HRA Pharma Investigational Site	Raleigh	North Carolina
United States	HRA Pharma Investigational Site	Rancho Cucamonga	California
United States	HRA Pharma Investigational Site	Saint Louis	Missouri
United States	HRA Pharma Investigational Site	Saint Louis	Missouri
United States	HRA Pharma Investigational Site	Saint Louis Park	Minnesota
United States	HRA Pharma Investigational Site	Saint Peters	Missouri
United States	HRA Pharma Investigational Site	Saint Petersburg	Florida
United States	HRA Pharma Investigational Site	Seattle	Washington
United States	HRA Pharma Investigational Site	Seattle	Washington
United States	HRA Pharma Investigational Site	Tacoma	Washington
United States	HRA Pharma Investigational Site	Tampa	Florida
United States	HRA Pharma Investigational Site	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.	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.	Up to 6 Weeks
Primary	Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.	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.	Up to 6 Weeks
Primary	Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.	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.	Day 1