A Study of Oral Contraception Under Simulated OTC Conditions
Status: | Terminated |
---|---|
Conditions: | Contraception, Contraception |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 2/27/2019 |
Start Date: | April 27, 2018 |
End Date: | November 14, 2018 |
A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)
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.
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 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.
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.
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:
- Cannot read, speak and understand English
- Cannot see well enough to read information on the label
We found this trial at
41
sites
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