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Completed

NCT Number: NCT04112095

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

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.

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Key information

Conditions

Contraception

Age range

11 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

HRA Pharma Investigational site 1012, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norgestrel 0.075 mg tablets

Drug

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.

Primary outcomes

  1. Self-Selection: Proportion of self-selection population who make a correct selection decision regarding use of the product.

    Time frame: One Day

    Measurement tool: interview

  2. Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

  3. Actual Use: Proportion of subjects who are adherent to daily dosing instructions.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

  4. Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

Secondary outcomes

  1. Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product.

    Time frame: One Day

    Measurement tool: interview

  2. Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

  3. Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

  4. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

  5. Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.

    Time frame: Up to 24 Weeks

    Measurement tool: electronic diary

  6. Actual Use: Proportion of user population who do not use study medication together with another form of hormone containing birth control.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview and electronic diary

  7. 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.

    Time frame: Two Days

    Measurement tool: electronic diary

  8. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  9. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  10. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  11. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  12. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  13. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  14. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  15. 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.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

  16. Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product.

    Time frame: Up to 24 Weeks

    Measurement tool: phone interview

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study title

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

Acronym: ACCESS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 2, 2019
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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