A Study of Oral Contraception Under Simulated OTC Conditions

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.

• Norgestrel 0.075 mg tablets (Drug), also known as Opill: 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 16 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.

Primary outcomes

• Self-selection [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 [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 [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 [Up to 16 weeks]: Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made

Secondary outcomes

• 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]: Proportion of user population who do not use study medication together with another form of hormone-containing birth control. Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
• 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 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 Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
• 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 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 Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made
• 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]: 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. Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made.
• 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]: 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 Measurement tool: phone interview Study prematurely discontinued No User endpoint calculations were made.
• Safety Population: Number of Pregnancies Reported During the Course of the Study [Up to 16 weeks]: Number of pregnancies reported during the course of the study Measurement tool: phone interview

Sex: Female, ages: 12 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Self-selection (Primary)
• Actual Use: Use of the Study Medication Every Day (Primary)
• Actual Use: Use of the Study Medication at the Same Time of Day (Primary)
• Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs (Primary)
• Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control. (Secondary)
• 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 (Secondary)
• 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 (Secondary)
• 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. (Secondary)
• 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 (Secondary)
• Safety Population: Number of Pregnancies Reported During the Course of the Study (Secondary), Number, participants: Use Phase Norgestrel 0.075 mg 1

Adverse events

Time frame: up to 16 weeks

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2017-12-15)
• Statistical Analysis Plan (PDF, 2020-03-20)

• Russell Bradford, MD, MSPH, Principal investigator, Pegus Research, Inc.