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

Contraception Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112095
• Other study ID #: 151042-004
• Status: Completed
• Phase: Phase 3
• Start date: September 6, 2019
• Est. completion date: August 5, 2021

Study information

• Verified date: May 2022
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 962
• Est. completion date: August 5, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
United States	HRA Pharma Investigational Site 1007	Albuquerque	New Mexico
United States	HRA Pharma Investigational Site 1009	Albuquerque	New Mexico
United States	HRA Pharma Investigational Site 1011	Andover	Minnesota
United States	HRA Pharma Investigational Site 1033	Aurora	Colorado
United States	HRA Pharma Investigational site 1012	Birmingham	Alabama
United States	HRA Pharma Investigational Site 1031	Bronx	New York
United States	HRA Pharma Investigational Site 1037	Bronx	New York
United States	HRA Pharma Investigational Site 1030	Bronxville	New York
United States	HRA Pharma Investigational Site 1015	Burlington	North Carolina
United States	HRA Pharma Investigational Site 1027	Cerritos	California
United States	HRA Pharma investigational site 1016	Clarksville	Tennessee
United States	HRA Pharma Investigational Site 1023	Dalton	Georgia
United States	HRA Pharma Investigational Site 1039	Downey	California
United States	HRA Pharma Investigational Site 1006	Elk River	Minnesota
United States	HRA Pharma Investigational Site 1021	Enumclaw	Washington
United States	HRA Pharma Investigational Site 1019	Framingham	Massachusetts
United States	HRA Pharma Investigational Site 1018	Griffin	Georgia
United States	HRA Pharma Investigational Site 1008	Homewood	Alabama
United States	HRA Pharma Investigational Site 1001	Houston	Texas
United States	HRA Pharma Investigational Site 1022	Houston	Texas
United States	HRA Pharma Investigational Site 1036	Lafayette Hill	Pennsylvania
United States	HRA Pharma Investigational Site 1017	Long Beach	California
United States	HRA Pharma investigational site 1035	Long Beach	California
United States	HRA Pharma Investigational Site 1028	Los Angeles	California
United States	HRA Pharma Investigational Site 1029	Los Angeles	California
United States	HRA Pharma Investigational Site 1034	Los Angeles	California
United States	HRA Pharma investigational site 1024	Mapleton	Utah
United States	HRA Pharma Investigational Site 1038	Mesa	Arizona
United States	HRA Pharma Investigational Site 1013	New York	New York
United States	HRA Pharma Investigational Site 1025	Philadelphia	Pennsylvania
United States	HRA Pharma Investigational Site 1032	Phoenix	Arizona
United States	HRA Pharma Investigational Site 1014	Rosedale	Maryland
United States	HRA Pharma Investigational Site 1003	Saint Francis	Minnesota
United States	HRA Pharma Investigational Site 1020	Saint Louis Park	Minnesota
United States	HRA Pharma Investigational Site 1040	Salt Lake City	Utah
United States	HRA Pharma Investigational site 1005	Seattle	Washington
United States	HRA Pharma Investigational site 1010	Snohomish	Washington
United States	HRA Pharma Investigational Site 1002	South Charleston	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Selection: Proportion of self-selection population who make a correct selection decision regarding use of the product.	Measurement tool: interview	One Day
Primary	Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.	Measurement tool: electronic diary	Up to 24 Weeks
Primary	Actual Use: Proportion of subjects who are adherent to daily dosing instructions.	Measurement tool: electronic diary	Up to 24 Weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.	Measurement tool: electronic diary	Up to 24 Weeks
Secondary	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
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.	Measurement tool: electronic diary	Two Days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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