Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
NCT ID: NCT04112095
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
962 participants
INTERVENTIONAL
2019-09-06
2021-08-05
Brief Summary
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Detailed Description
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Respondents to advertisements will either call the study phone line or visit the study website for prescreening 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 obtain (pharmacy sites) or be given (clinic sites) the study product.
Approximately 35 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
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
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 every day for up to 24 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 24 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 24 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cannot see well enough to read information on the label
11 Years
FEMALE
Yes
Sponsors
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HRA Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Russ Bradford, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Pegus Research, Inc.
Locations
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HRA Pharma Investigational site 1012
Birmingham, Alabama, United States
HRA Pharma Investigational Site 1008
Homewood, Alabama, United States
HRA Pharma Investigational Site 1038
Mesa, Arizona, United States
HRA Pharma Investigational Site 1032
Phoenix, Arizona, United States
HRA Pharma Investigational Site 1027
Cerritos, California, United States
HRA Pharma Investigational Site 1039
Downey, California, United States
HRA Pharma investigational site 1035
Long Beach, California, United States
HRA Pharma Investigational Site 1017
Long Beach, California, United States
HRA Pharma Investigational Site 1034
Los Angeles, California, United States
HRA Pharma Investigational Site 1029
Los Angeles, California, United States
HRA Pharma Investigational Site 1028
Los Angeles, California, United States
HRA Pharma Investigational Site 1033
Aurora, Colorado, United States
HRA Pharma Investigational Site 1023
Dalton, Georgia, United States
HRA Pharma Investigational Site 1018
Griffin, Georgia, United States
HRA Pharma Investigational Site 1014
Rosedale, Maryland, United States
HRA Pharma Investigational Site 1019
Framingham, Massachusetts, United States
HRA Pharma Investigational Site 1011
Andover, Minnesota, United States
HRA Pharma Investigational Site 1006
Elk River, Minnesota, United States
HRA Pharma Investigational Site 1003
Saint Francis, Minnesota, United States
HRA Pharma Investigational Site 1020
Saint Louis Park, Minnesota, United States
HRA Pharma Investigational Site 1009
Albuquerque, New Mexico, United States
HRA Pharma Investigational Site 1007
Albuquerque, New Mexico, United States
HRA Pharma Investigational Site 1030
Bronxville, New York, United States
HRA Pharma Investigational Site 1013
New York, New York, United States
HRA Pharma Investigational Site 1037
The Bronx, New York, United States
HRA Pharma Investigational Site 1031
The Bronx, New York, United States
HRA Pharma Investigational Site 1015
Burlington, North Carolina, United States
HRA Pharma Investigational Site 1002
South Charleston, Ohio, United States
HRA Pharma Investigational Site 1036
Lafayette Hill, Pennsylvania, United States
HRA Pharma Investigational Site 1025
Philadelphia, Pennsylvania, United States
HRA Pharma investigational site 1016
Clarksville, Tennessee, United States
HRA Pharma Investigational Site 1022
Houston, Texas, United States
HRA Pharma Investigational Site 1001
Houston, Texas, United States
HRA Pharma investigational site 1024
Mapleton, Utah, United States
HRA Pharma Investigational Site 1040
Salt Lake City, Utah, United States
HRA Pharma Investigational Site 1021
Enumclaw, Washington, United States
HRA Pharma Investigational site 1005
Seattle, Washington, United States
HRA Pharma Investigational site 1010
Snohomish, Washington, United States
Countries
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Other Identifiers
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151042-004
Identifier Type: -
Identifier Source: org_study_id
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