A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 189
- Locations
- 3
- Primary Endpoint
- Self-selection
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Use Phase Norgestrel 0.075 mg
Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks
Intervention: Norgestrel 0.075 mg tablets (Drug)
Outcomes
Primary Outcomes
Self-selection
Time Frame: Day One
Proportion of self-selection population who make a correct selection decision regarding use of the product Study prematuraly discontinued No Self-selection endpoint calculations were made.
Actual Use: Use of the Study Medication Every Day
Time Frame: Up to 16 weeks
Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made
Actual Use: Use of the Study Medication at the Same Time of Day
Time Frame: Up to 16 weeks
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.
Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs
Time Frame: Up to 16 weeks
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
Secondary Outcomes
- Proportion of User Population Who Experience One of the "Talk to a Doctor" Conditions Listed Within the "When Using This Product" or "Stop Use and Ask a Doctor" Sections(Up to 16 weeks)
- Safety Population: Number of Pregnancies Reported During the Course of the Study(Up to 16 weeks)
- Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control.(Up to 16 weeks)
- Actual Use: Proportion of User Population Who Report Using a Barrier Method of Contraception (or Abstaining From Intercourse) for the First 48 Hours After Starting to Use the Study Medication(Up to 16 weeks)
- Proportion of Self-selection Population Taking One of the "Ask a Doctor or Pharmacist Before Use" Products Who do Not Select, Who Select But do Not Use, or Who Report Contacting a Healthcare Provider or Pharmacist About Use of the Product(Up to 16 weeks)
- Proportion of Self-selection Population Who Report Having Liver Problems Who Either do Not Select ,Who Select But do Not Use, or Who Report Contacting a Healthcare Provider About Use of the Product.(Up to 16 weeks)