Status and phase
Conditions
Treatments
About
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.
Full description
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 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
-Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral contraception for their own use for the purposes of the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
189 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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