Clinical trial NCT04112095: Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
Official title: Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Daily birth control
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 962
Sex: FEMALE
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Selection: Proportion of self-selection population who make a correct selection decision regarding use of the product.
timeFrame: One Day
measure: Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.
timeFrame: Up to 24 Weeks
measure: Actual Use: Proportion of subjects who are adherent to daily dosing instructions.
timeFrame: Up to 24 Weeks
measure: Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day.
timeFrame: Up to 24 Weeks
Secondary outcomes:
measure: Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product.
timeFrame: One Day
measure: Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors.
timeFrame: Up to 24 Weeks
measure: Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.
timeFrame: Up to 24 Weeks
measure: Actual Use: Proportion of user population who do not use study medication together with another form of hormone containing birth control.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Two Days
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: 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.
timeFrame: Up to 24 Weeks
measure: Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product.
timeFrame: Up to 24 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: HRA Pharma Investigational site 1012
state: Alabama
city: Homewood
country: United States
facility: HRA Pharma Investigational Site 1008
state: Alabama
city: Mesa
country: United States
facility: HRA Pharma Investigational Site 1038
state: Arizona
city: Phoenix
country: United States
facility: HRA Pharma Investigational Site 1032
state: Arizona
city: Cerritos
country: United States
facility: HRA Pharma Investigational Site 1027
state: California
city: Downey
country: United States
facility: HRA Pharma Investigational Site 1039
state: California
city: Long Beach
country: United States
facility: HRA Pharma investigational site 1035
state: California
city: Long Beach
country: United States
facility: HRA Pharma Investigational Site 1017
state: California
city: Los Angeles
country: United States
facility: HRA Pharma Investigational Site 1034
state: California
city: Los Angeles
country: United States
facility: HRA Pharma Investigational Site 1029
state: California
city: Los Angeles
country: United States
facility: HRA Pharma Investigational Site 1028
state: California
city: Aurora
country: United States
facility: HRA Pharma Investigational Site 1033
state: Colorado
city: Dalton
country: United States
facility: HRA Pharma Investigational Site 1023
state: Georgia
city: Griffin
country: United States
facility: HRA Pharma Investigational Site 1018
state: Georgia
city: Rosedale
country: United States
facility: HRA Pharma Investigational Site 1014
state: Maryland
city: Framingham
country: United States
facility: HRA Pharma Investigational Site 1019
state: Massachusetts
city: Andover
country: United States
facility: HRA Pharma Investigational Site 1011
state: Minnesota
city: Elk River
country: United States
facility: HRA Pharma Investigational Site 1006
state: Minnesota
city: Saint Francis
country: United States
facility: HRA Pharma Investigational Site 1003
state: Minnesota
city: Saint Louis Park
country: United States
facility: HRA Pharma Investigational Site 1020
state: Minnesota
city: Albuquerque
country: United States
facility: HRA Pharma Investigational Site 1009
state: New Mexico
city: Albuquerque
country: United States
facility: HRA Pharma Investigational Site 1007
state: New Mexico
city: Bronxville
country: United States
facility: HRA Pharma Investigational Site 1030
state: New York
city: Bronx
country: United States
facility: HRA Pharma Investigational Site 1037
state: New York
city: Bronx
country: United States
facility: HRA Pharma Investigational Site 1031
state: New York
city: New York
country: United States
facility: HRA Pharma Investigational Site 1013
state: New York
city: Burlington
country: United States
facility: HRA Pharma Investigational Site 1015
state: North Carolina
city: South Charleston
country: United States
facility: HRA Pharma Investigational Site 1002
state: Ohio
city: Lafayette Hill
country: United States
facility: HRA Pharma Investigational Site 1036
state: Pennsylvania
city: Philadelphia
country: United States
facility: HRA Pharma Investigational Site 1025
state: Pennsylvania
city: Clarksville
country: United States
facility: HRA Pharma investigational site 1016
state: Tennessee
city: Houston
country: United States
facility: HRA Pharma Investigational Site 1022
state: Texas
city: Houston
country: United States
facility: HRA Pharma Investigational Site 1001
state: Texas
city: Mapleton
country: United States
facility: HRA Pharma investigational site 1024
state: Utah
city: Salt Lake City
country: United States
facility: HRA Pharma Investigational Site 1040
state: Utah
city: Enumclaw
country: United States
facility: HRA Pharma Investigational Site 1021
state: Washington
city: Seattle
country: United States
facility: HRA Pharma Investigational site 1005
state: Washington
city: Snohomish
country: United States
facility: HRA Pharma Investigational site 1010
state: Washington
Study officials:
affiliation: Pegus Research, Inc.
name: Russ Bradford, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: