Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 900
Summary
- Conditions
- Contraception
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Drug: Norgestrel 0.075 mg tablets All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 24 weeks. Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 11 years and 125 years
- Gender
- Only males
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 enrollme...
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.
Tracking Information
- NCT #
- NCT04112095
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Russ Bradford, MD, MSPH Pegus Research, Inc.
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