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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208985
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
HRA Pharma

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.

Condition or disease Intervention/treatment Phase
Emergency Contraception Drug: Use Phase (Ulipristal Acetate, 30 mg) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : June 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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).





Primary Outcome Measures :
  1. Proportion of dosing instances among user population taken within 120 hours (5 days) of most recent episode of unprotected sex. [ Time Frame: Up to 6 Weeks ]
  2. Proportion of dosing instances among user population in which no more than one tablet was taken. [ Time Frame: Up to 6 Weeks ]
  3. Proportion of female selectors who are not pregnant at the time of selection decision. [ Time Frame: Day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208985


Locations
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United States, California
HRA Pharma Investigational Site
Rancho Cucamonga, California, United States, 91730
United States, Colorado
HRA Pharma Investigational Site
Boulder, Colorado, United States, 80302
HRA Pharma Investigational Site
Denver, Colorado, United States, 80003
HRA Pharma Investigational Site
Denver, Colorado, United States, 80207
United States, Florida
HRA Pharma Investigational Site
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
United States, Illinois
HRA Pharma Investigational Site
Belleville, Illinois, United States, 62226
United States, Minnesota
HRA Pharma Investigational Site
Andover, Minnesota, United States, 55304
HRA Pharma Investigational Site
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
HRA Pharma Investigational Site
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
United States, Nevada
HRA Pharma Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
HRA Pharma Investigational Site
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
United States, New Mexico
HRA Pharma Investigational Site
Albuquerque, New Mexico, United States, 87104
HRA Pharma Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
HRA Pharma Investigational Site
New York, New York, United States, 10012
United States, North Carolina
HRA Pharma Investigational Site
Durham, North Carolina, United States, 27704
HRA Pharma Investigational Site
Raleigh, North Carolina, United States, 27603
United States, Oregon
HRA Pharma Investigational Site
Portland, Oregon, United States, 97212
United States, Washington
HRA Pharma Investigational Site
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
Sponsors and Collaborators
HRA Pharma
Investigators
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Principal Investigator: Russel Bradford, MD, MSPH Pegus Research, Inc.

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Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT03208985    
Other Study ID Numbers: 151032-001
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HRA Pharma:
Emergency contraception
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs