A Study of Oral Contraception Under Simulated OTC Conditions
NCT ID: NCT03559010
Last Updated: 2022-04-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
189 participants
INTERVENTIONAL
2018-04-27
2018-11-14
Brief Summary
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Detailed Description
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Respondents to advertisements will either call Clinical Research Organization (CRO) call center or visit the study website for initial screening (during which data regarding age, gender, and minimal study exclusion criteria will be collected) and scheduling of an in-person enrollment visit at a local participating research site.
During the face-to-face enrollment visit, potential subjects who meet the inclusion and exclusion criteria for the study will be given an (empty) study medication package and will be allowed as much time as they need to review the information on the outside of the entire package. Subjects will then be asked if the product is OK or not OK for them to use.
Qualified subjects then will be allowed to purchase (pharmacy sites) or be given (clinic sites) the study product.
Approximately 47 sites will be used, comprising retail pharmacy research sites and women's health clinics or adolescents' clinics.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Use Phase Norgestrel 0.075 mg
Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks
Norgestrel 0.075 mg tablets
All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.
Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet.
Interventions
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Norgestrel 0.075 mg tablets
All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.
Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cannot see well enough to read information on the label
12 Years
FEMALE
Yes
Sponsors
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HRA Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Russell Bradford, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Pegus Research, Inc.
Locations
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HRA Pharma Investigational site
Birmingham, Alabama, United States
HRA Pharma Investigational site
Homewood, Alabama, United States
HRA Pharma Investigational site
McCalla, Alabama, United States
HRA Pharma Investigational site
Tucson, Arizona, United States
HRA Pharma Investigational site
Downey, California, United States
HRA Pharma Investigational site
La Habra, California, United States
HRA Pharma Investigational site
Long Beach, California, United States
HRA Pharma Investigational site
Los Angeles, California, United States
HRA Pharma Investigational site
Bridgeport, Connecticut, United States
HRA Pharma Investigational site
Hartford, Connecticut, United States
HRA Pharma Investigational site
New Haven, Connecticut, United States
HRA Pharma Investigational site
Riverview, Florida, United States
HRA Pharma Investigational site
Dalton, Georgia, United States
HRA Pharma Investigational site
Griffin, Georgia, United States
HRA Pharma Investigational site
Catonsville, Maryland, United States
HRA Pharma Investigational site
Anoka, Minnesota, United States
HRA Pharma Investigational site
Elk River, Minnesota, United States
HRA Pharma Investigational site
Fridley, Minnesota, United States
HRA Pharma Investigational Site
Saint Francis, Minnesota, United States
HRA Pharma Investigational site
Elsberry, Missouri, United States
HRA Pharma Investigational site
Manchester, Missouri, United States
HRA Pharma Investigational Site
Savannah, Missouri, United States
HRA Pharma Investigational site
Springfield, Missouri, United States
HRA Pharma Investigational site
Monroe, 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
Albuquerque, New Mexico, United States
HRA Pharma Investigational site
Burlington, North Carolina, United States
HRA Pharma Investigational Site
South Charleston, Ohio, United States
HRA Pharma Investigational site
Bethlehem, Pennsylvania, United States
HRA Pharma Investigational site
Clarksville, Tennessee, United States
HRA Pharma Investigational site
Cleveland, Tennessee, United States
HRA Pharma Investigational site
Houston, Texas, United States
HRA Pharma Investigational site
Houston, Texas, United States
HRA Pharma Investigational site
Sherman, Texas, United States
HRA Investigational site
Bountiful, Utah, United States
HRA Pharma Investigational site
Mapleton, Utah, United States
HRA Pharma Investigational site
Syracuse, Utah, United States
HRA Pharma Investigational site
Montpelier, Virginia, United States
HRA Pharma Investigational site
Enumclaw, Washington, United States
HRA Pharma Investigational site
Kenmore, Washington, United States
HRA Pharma Investigational site
Seattle, Washington, United States
HRA Pharma Investigational site
Snohomish, Washington, United States
HRA Pharma Investigational site
Amery, Wisconsin, 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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151042-001
Identifier Type: -
Identifier Source: org_study_id
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