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

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

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.

Study Overview

• Status: Completed
• Conditions: Emergency Contraception
• Intervention / Treatment: Drug: Use Phase (Ulipristal Acetate, 30 mg)

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.

• Study Type: Interventional
• Enrollment (Actual): 1270
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Cucamonga, California, United States, 91730
      • HRA Pharma Investigational site
  • Colorado
    • Boulder, Colorado, United States, 80302
      • HRA Pharma Investigational site
    • Denver, Colorado, United States, 80003
      • HRA Pharma Investigational site
    • Denver, Colorado, United States, 80207
      • HRA Pharma Investigational site
  • Florida
    • Fort Myers, Florida, United States, 33919
      • HRA Pharma Investigational site
    • Miami, Florida, United States, 33133
      • HRA Pharma Investigational site
    • Orlando, Florida, United States, 32817
      • HRA Pharma Investigational site
    • Pembroke Pines, Florida, United States, 33026
      • HRA Pharma Investigational site
    • Saint Petersburg, Florida, United States, 33701
      • HRA Pharma Investigational site
    • Tampa, Florida, United States, 33617
      • HRA Pharma Investigational site
  • Illinois
    • Belleville, Illinois, United States, 62226
      • HRA Pharma Investigational site
  • Minnesota
    • Andover, Minnesota, United States, 55304
      • HRA Pharma Investigational site
    • Saint Louis Park, Minnesota, United States, 55426
      • HRA Pharma Investigational site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • HRA Pharma Investigational site
    • Manchester, Missouri, United States, 63088
      • HRA Pharma Investigational site
    • Saint Louis, Missouri, United States, 63108
      • HRA Pharma Investigational site
    • Saint Louis, Missouri, United States, 63118
      • HRA Pharma Investigational site
    • Saint Peters, Missouri, United States, 63376
      • HRA Pharma Investigational site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • HRA Pharma Investigational site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • HRA Pharma Investigational site
    • Morristown, New Jersey, United States, 07960
      • HRA Pharma Investigational site
    • New Brunswick, New Jersey, United States, 08901
      • HRA Pharma Investigational site
    • Trenton, New Jersey, United States, 08608
      • HRA Pharma Investigational site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87104
      • HRA Pharma Investigational site
    • Albuquerque, New Mexico, United States, 87109
      • HRA Pharma Investigational site
  • New York
    • New York, New York, United States, 10012
      • HRA Pharma Investigational site
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • HRA Pharma Investigational site
    • Raleigh, North Carolina, United States, 27603
      • HRA Pharma Investigational site
  • Oregon
    • Portland, Oregon, United States, 97212
      • HRA Pharma Investigational site
  • Washington
    • Bremerton, Washington, United States, 98310
      • HRA Pharma Investigational site
    • Puyallup, Washington, United States, 98373
      • HRA Pharma Investigational site
    • Seattle, Washington, United States, 98122
      • HRA Pharma Investigational site
    • Seattle, Washington, United States, 98133
      • HRA Pharma Investigational site
    • Tacoma, Washington, United States, 98405
      • HRA Pharma Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Use Phase (Ulipristal Acetate, 30 mg); One tablet of 30 mg of ulipristal acetate for emergency contraception

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: HRA Pharma
• Investigators: Principal Investigator: Russel Bradford, MD, MSPH, Pegus Research, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2017
• Primary Completion (ACTUAL): June 14, 2018
• Study Completion (ACTUAL): June 14, 2018

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Emergency contraception
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: 151032-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No