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

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Norgestrel 0.075 mg tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 962
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • HRA Pharma Investigational site 1012
    • Homewood, Alabama, United States, 35209
      • HRA Pharma Investigational Site 1008
  • Arizona
    • Mesa, Arizona, United States, 85203
      • HRA Pharma Investigational Site 1038
    • Phoenix, Arizona, United States, 85021
      • HRA Pharma Investigational Site 1032
  • California
    • Cerritos, California, United States, 90703
      • HRA Pharma Investigational Site 1027
    • Downey, California, United States, 90242
      • HRA Pharma Investigational Site 1039
    • Long Beach, California, United States, 90806
      • HRA Pharma investigational site 1035
    • Long Beach, California, United States, 90815
      • HRA Pharma Investigational Site 1017
    • Los Angeles, California, United States, 90005
      • HRA Pharma Investigational Site 1034
    • Los Angeles, California, United States, 90036
      • HRA Pharma Investigational Site 1029
    • Los Angeles, California, United States, 90057
      • HRA Pharma Investigational Site 1028
  • Colorado
    • Aurora, Colorado, United States, 80045
      • HRA Pharma Investigational Site 1033
  • Georgia
    • Dalton, Georgia, United States, 30721
      • HRA Pharma Investigational Site 1023
    • Griffin, Georgia, United States, 30224
      • HRA Pharma Investigational Site 1018
  • Maryland
    • Rosedale, Maryland, United States, 21237
      • HRA Pharma Investigational Site 1014
  • Massachusetts
    • Framingham, Massachusetts, United States, 01702
      • HRA Pharma Investigational Site 1019
  • Minnesota
    • Andover, Minnesota, United States, 55304
      • HRA Pharma Investigational Site 1011
    • Elk River, Minnesota, United States, 55330
      • HRA Pharma Investigational Site 1006
    • Saint Francis, Minnesota, United States, 55070
      • HRA Pharma Investigational Site 1003
    • Saint Louis Park, Minnesota, United States, 55426
      • HRA Pharma Investigational Site 1020
  • New Mexico
    • Albuquerque, New Mexico, United States, 87104
      • HRA Pharma Investigational Site 1009
    • Albuquerque, New Mexico, United States, 97110
      • HRA Pharma Investigational Site 1007
  • New York
    • Bronx, New York, United States, 10463
      • HRA Pharma Investigational Site 1037
    • Bronx, New York, United States, 10467
      • HRA Pharma Investigational Site 1031
    • Bronxville, New York, United States, 10708
      • HRA Pharma Investigational Site 1030
    • New York, New York, United States, 10034
      • HRA Pharma Investigational Site 1013
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • HRA Pharma Investigational Site 1015
  • Ohio
    • South Charleston, Ohio, United States, 45368
      • HRA Pharma Investigational Site 1002
  • Pennsylvania
    • Lafayette Hill, Pennsylvania, United States, 19444
      • HRA Pharma Investigational Site 1036
    • Philadelphia, Pennsylvania, United States, 19136
      • HRA Pharma Investigational Site 1025
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • HRA Pharma investigational site 1016
  • Texas
    • Houston, Texas, United States, 77008
      • HRA Pharma Investigational Site 1022
    • Houston, Texas, United States, 77099
      • HRA Pharma Investigational Site 1001
  • Utah
    • Mapleton, Utah, United States, 84664
      • HRA Pharma investigational site 1024
    • Salt Lake City, Utah, United States, 84101
      • HRA Pharma Investigational Site 1040
  • Washington
    • Enumclaw, Washington, United States, 98022
      • HRA Pharma Investigational Site 1021
    • Seattle, Washington, United States, 98117
      • HRA Pharma Investigational site 1005
    • Snohomish, Washington, United States, 98290
      • HRA Pharma Investigational site 1010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Use Phase Norgestrel 0.075 mg; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HRA Pharma
• Investigators: Principal Investigator: Russ Bradford, MD, MSPH, Pegus Research, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2019
• Primary Completion (ACTUAL): August 5, 2021
• Study Completion (ACTUAL): August 5, 2021

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Daily birth control
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Norgestrel
• Other Study ID Numbers: 151042-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No