A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
NCT ID: NCT03208985
Last Updated: 2022-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1270 participants
INTERVENTIONAL
2017-05-23
2018-06-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Use Phase (Ulipristal Acetate, 30 mg)
One tablet of 30 mg of ulipristal acetate for emergency contraception
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cannot see well enough to read information on the label
FEMALE
Yes
Sponsors
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HRA Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Russel Bradford, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Pegus Research, Inc.
Locations
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HRA Pharma Investigational Site
Rancho Cucamonga, California, United States
HRA Pharma Investigational Site
Boulder, Colorado, United States
HRA Pharma Investigational Site
Denver, Colorado, United States
HRA Pharma Investigational Site
Denver, Colorado, United States
HRA Pharma Investigational Site
Fort Myers, Florida, United States
HRA Pharma Investigational Site
Miami, Florida, United States
HRA Pharma Investigational Site
Orlando, Florida, United States
HRA Pharma Investigational Site
Pembroke Pines, Florida, United States
HRA Pharma Investigational Site
St. Petersburg, Florida, United States
HRA Pharma Investigational Site
Tampa, Florida, United States
HRA Pharma Investigational Site
Belleville, Illinois, United States
HRA Pharma Investigational Site
Andover, Minnesota, United States
HRA Pharma Investigational Site
Saint Louis Park, Minnesota, United States
HRA Pharma Investigational Site
City of Saint Peters, Missouri, United States
HRA Pharma Investigational Site
Kansas City, Missouri, United States
HRA Pharma Investigational Site
Manchester, Missouri, United States
HRA Pharma Investigational Site
St Louis, Missouri, United States
HRA Pharma Investigational Site
St Louis, Missouri, United States
HRA Pharma Investigational Site
Las Vegas, Nevada, United States
HRA Pharma Investigational Site
Hackensack, New Jersey, 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
Trenton, New Jersey, United States
HRA Pharma Investigational Site
Albuquerque, New Mexico, United States
HRA Pharma Investigational Site
Albuquerque, New Mexico, United States
HRA Pharma Investigational Site
New York, New York, United States
HRA Pharma Investigational Site
Durham, North Carolina, United States
HRA Pharma Investigational Site
Raleigh, North Carolina, United States
HRA Pharma Investigational Site
Portland, Oregon, United States
HRA Pharma Investigational Site
Bremerton, Washington, United States
HRA Pharma Investigational Site
Puyallup, Washington, 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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151032-001
Identifier Type: -
Identifier Source: org_study_id
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