Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-11 @ 7:14 PM
Study NCT ID:
NCT04112095
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2019-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
Sponsor:
HRA Pharma
Organization:
Study Overview
Official Title:
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCESS
Brief Summary:
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: