Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)

HRA Pharma

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: Norgestrel 0.075 mg tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT04112095

151042-004

Details and patient eligibility

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 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.

Enrollment

962 patients

Sex

Female

Ages

11+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women who are willing to purchase (in the pharmacies) or be provided (in the clinics, for women younger than 18 years old) oral contraception for their own use for the purposes of the study

Exclusion criteria