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

Primary Purpose

Emergency Contraception

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Use Phase (Ulipristal Acetate, 30 mg)
Sponsored by
HRA Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergency Contraception focused on measuring Emergency contraception

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site
  • HRA Pharma Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use Phase (Ulipristal Acetate, 30 mg)

Arm Description

One tablet of 30 mg of ulipristal acetate for emergency contraception

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2017
Last Updated
November 16, 2022
Sponsor
HRA Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03208985
Brief Title
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Acronym
LIBRella
Official Title
A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HRA Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Contraception
Keywords
Emergency contraception

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use Phase (Ulipristal Acetate, 30 mg)
Arm Type
Experimental
Arm Description
One tablet of 30 mg of ulipristal acetate for emergency contraception
Intervention Type
Drug
Intervention Name(s)
Use Phase (Ulipristal Acetate, 30 mg)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
Description
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.
Time Frame
Up to 6 Weeks
Title
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
Description
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.
Time Frame
Up to 6 Weeks
Title
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russel Bradford, MD, MSPH
Organizational Affiliation
Pegus Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
HRA Pharma Investigational Site
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80302
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80003
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80207
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32817
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Andover
State/Province
Minnesota
ZIP/Postal Code
55304
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Manchester
State/Province
Missouri
ZIP/Postal Code
63088
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
HRA Pharma Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08608
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87104
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
HRA Pharma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97212
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98373
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
HRA Pharma Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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