Loading clinical trials...
Loading clinical trials...
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.
Subjects will be primarily recruited via passive recruiting methods, such as in-store posters, direct mail postcards, and digital space advertising. 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.
Age
11 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
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
Start Date
September 6, 2019
Primary Completion Date
August 5, 2021
Completion Date
August 5, 2021
Last Updated
May 20, 2022
962
ACTUAL participants
Norgestrel 0.075 mg tablets
DRUG
Lead Sponsor
HRA Pharma
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06672016