Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use

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 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.

Official Title
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Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)

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 to purchase (in the pharmacies) or be provided (in the clinics, for women younger than 18 years old) 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: 11 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
Interventional 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)


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 every day for up to 24 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 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.<br>|

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. | Measurement tool: interview | One Day | 
| Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product. | Measurement tool: electronic diary | Up to 24 Weeks | 
| Actual Use: Proportion of subjects who are adherent to daily dosing instructions. | Measurement tool: electronic diary | Up to 24 Weeks | 
| Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day. | Measurement tool: electronic diary | Up to 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product. | Measurement tool: interview | One Day | 
| Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors. | Measurement tool: electronic diary | Up to 24 Weeks | 
| Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors. | Measurement tool: electronic diary | Up to 24 Weeks | 
| Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product within 27 hours of the previous dose, accounting for appropriate mitigating behaviors. | Measurement tool: electronic diary | Up to 24 Weeks | 
| Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs. | Measurement tool: electronic diary | Up to 24 Weeks | 
| Actual Use: Proportion of user population who do not use study medication together with another form of hormone containing birth control. | Measurement tool: phone interview and electronic diary | Up to 24 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. | Measurement tool: electronic diary | Two Days | 
| Self-Select/Use: Proportion of self-select population taking products listed in the ask a doctor or pharmacist before use section of the label who do not select, who select but do not use, or who report contacting a HCP on product use. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Proportion of user population who become pregnant during the course of the study who report stopping use and seeking healthcare as directed by the label. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Proportion of user population who develop sudden or severe pain in their lower belly during the course of the study who report seeking healthcare as directed by the label. | Measurement tool: phone interview | Up to 24 Weeks | 
| Use: Proportion of users having a late period after missing any pills in the last month, not having a period for 2 months during the course of the study who report doing a pregnancy test or seeking healthcare as directed by the label or who stop use. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Proportion of user population who experience periods that last more than 8 days or are unusually heavy during the course of the study who report seeking healthcare as directed by the label or who stop use. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Proportion of user population who experience repeated vaginal bleeding brought on by sex during the course of the study who report seeking healthcare as directed by the label or who stop use. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Proportion of user population who start having migraines with aura or whose migraines get worse during the course of the study who report seeking healthcare as directed by the label or who stop use. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Proportion of user population who develop yellowing of the skin or whites of the eyes during the course of the study who report seeking healthcare as directed by the label. | Measurement tool: phone interview | Up to 24 Weeks | 
| Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product. | Measurement tool: phone interview | Up to 24 Weeks | 

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