Clinical trial NCT03208985: A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Official title: A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Emergency Contraception
Keywords: Emergency contraception
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 1270
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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

Primary outcomes:
measure: Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
timeFrame: Up to 6 Weeks
measure: Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
timeFrame: Up to 6 Weeks
measure: Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Cucamonga
country: United States
facility: HRA Pharma Investigational Site
state: California
city: Boulder
country: United States
facility: HRA Pharma Investigational Site
state: Colorado
city: Denver
country: United States
facility: HRA Pharma Investigational Site
state: Colorado
city: Denver
country: United States
facility: HRA Pharma Investigational Site
state: Colorado
city: Fort Myers
country: United States
facility: HRA Pharma Investigational Site
state: Florida
city: Miami
country: United States
facility: HRA Pharma Investigational Site
state: Florida
city: Orlando
country: United States
facility: HRA Pharma Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: HRA Pharma Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: HRA Pharma Investigational Site
state: Florida
city: Tampa
country: United States
facility: HRA Pharma Investigational Site
state: Florida
city: Belleville
country: United States
facility: HRA Pharma Investigational Site
state: Illinois
city: Andover
country: United States
facility: HRA Pharma Investigational Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: HRA Pharma Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: HRA Pharma Investigational Site
state: Missouri
city: Manchester
country: United States
facility: HRA Pharma Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: HRA Pharma Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: HRA Pharma Investigational Site
state: Missouri
city: Saint Peters
country: United States
facility: HRA Pharma Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: HRA Pharma Investigational Site
state: Nevada
city: Hackensack
country: United States
facility: HRA Pharma Investigational Site
state: New Jersey
city: Morristown
country: United States
facility: HRA Pharma Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: HRA Pharma Investigational Site
state: New Jersey
city: Trenton
country: United States
facility: HRA Pharma Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: HRA Pharma Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: HRA Pharma Investigational Site
state: New Mexico
city: New York
country: United States
facility: HRA Pharma Investigational Site
state: New York
city: Durham
country: United States
facility: HRA Pharma Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: HRA Pharma Investigational Site
state: North Carolina
city: Portland
country: United States
facility: HRA Pharma Investigational Site
state: Oregon
city: Bremerton
country: United States
facility: HRA Pharma Investigational Site
state: Washington
city: Puyallup
country: United States
facility: HRA Pharma Investigational Site
state: Washington
city: Seattle
country: United States
facility: HRA Pharma Investigational Site
state: Washington
city: Seattle
country: United States
facility: HRA Pharma Investigational Site
state: Washington
city: Tacoma
country: United States
facility: HRA Pharma Investigational Site
state: Washington
Study officials:
affiliation: Pegus Research, Inc.
name: Russel Bradford, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: