A Study of Oral Contraception Under Simulated OTC Conditions

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)

Conditions
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Contraception

Intervention / Treatment
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* Drug: Norgestrel 0.075 mg tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use Phase Norgestrel 0.075 mg<br>Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks | Drug: Norgestrel 0.075 mg tablets<br>* 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.<br>* Other names: Opill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-selection | 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. | Day One | 
| Actual Use: Use of the Study Medication Every Day | Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made | Up to 16 weeks | 
| Actual Use: Use of the Study Medication at the Same Time of Day | Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made. | Up to 16 weeks | 
| Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs | Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control. | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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 | 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. | Up to 16 weeks | 
| Safety Population: Number of Pregnancies Reported During the Course of the Study | Number of pregnancies reported during the course of the study Measurement tool: phone interview | Up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Daily birth control