A Study of Oral Contraception Under Simulated OTC Conditions (OPTION)

A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)

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: Terminated
• 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 Clinical Research Organization (CRO) call center or visit the study website for initial screening (during which data regarding age, gender, and minimal study exclusion criteria will be collected) 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 purchase (pharmacy sites) or be given (clinic sites) the study product.

Approximately 47 sites will be used, comprising retail pharmacy research sites and women's health clinics or adolescents' clinics.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • HRA Pharma Investigational site
    • Homewood, Alabama, United States, 35209
      • HRA Pharma Investigational site
    • McCalla, Alabama, United States, 35111
      • HRA Pharma Investigational site
  • Arizona
    • Tucson, Arizona, United States, 85704
      • HRA Pharma Investigational site
  • California
    • Downey, California, United States, 90241
      • HRA Pharma Investigational site
    • La Habra, California, United States, 90631
      • HRA Pharma Investigational site
    • Long Beach, California, United States, 90806
      • HRA Pharma Investigational site
    • Los Angeles, California, United States, 90005
      • HRA Pharma Investigational site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • HRA Pharma Investigational site
    • Hartford, Connecticut, United States, 61121
      • HRA Pharma Investigational site
    • New Haven, Connecticut, United States, 65111
      • HRA Pharma Investigational site
  • Florida
    • Riverview, Florida, United States, 33578
      • HRA Pharma Investigational site
  • Georgia
    • Dalton, Georgia, United States, 30721
      • HRA Pharma Investigational site
    • Griffin, Georgia, United States, 30224
      • HRA Pharma Investigational site
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • HRA Pharma Investigational site
  • Minnesota
    • Anoka, Minnesota, United States, 55303
      • HRA Pharma Investigational site
    • Elk River, Minnesota, United States, 55330
      • HRA Pharma Investigational site
    • Fridley, Minnesota, United States, 55432
      • HRA Pharma Investigational site
    • Saint Francis, Minnesota, United States, 55070
      • HRA Pharma Investigational site
  • Missouri
    • Elsberry, Missouri, United States, 63343
      • HRA Pharma Investigational site
    • Manchester, Missouri, United States, 63088
      • HRA Pharma Investigational site
    • Savannah, Missouri, United States, 64485
      • HRA Pharma Investigational site
    • Springfield, Missouri, United States, 65807
      • HRA Pharma Investigational site
  • New Jersey
    • Monroe, New Jersey, United States, 08831
      • HRA Pharma Investigational site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87104
      • HRA Pharma Investigational site
    • Albuquerque, New Mexico, United States, 87109
      • HRA Pharma Investigational site
    • Albuquerque, New Mexico, United States, 87110
      • HRA Pharma Investigational site
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • HRA Pharma Investigational site
  • Ohio
    • South Charleston, Ohio, United States, 45368
      • HRA Pharma Investigational site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • HRA Pharma Investigational site
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • HRA Pharma Investigational site
    • Cleveland, Tennessee, United States, 37311
      • HRA Pharma Investigational site
  • Texas
    • Houston, Texas, United States, 77008
      • HRA Pharma Investigational site
    • Houston, Texas, United States, 77099
      • HRA Pharma Investigational site
    • Sherman, Texas, United States, 75092
      • HRA Pharma Investigational site
  • Utah
    • Bountiful, Utah, United States, 84010
      • HRA Investigational site
    • Mapleton, Utah, United States, 84664
      • HRA Pharma Investigational site
    • Syracuse, Utah, United States, 84075
      • HRA Pharma Investigational site
  • Virginia
    • Montpelier, Virginia, United States, 23192
      • HRA Pharma Investigational site
  • Washington
    • Enumclaw, Washington, United States, 98022
      • HRA Pharma Investigational site
    • Kenmore, Washington, United States, 98028
      • HRA Pharma Investigational site
    • Seattle, Washington, United States, 98117
      • HRA Pharma Investigational site
    • Snohomish, Washington, United States, 98290
      • HRA Pharma Investigational site
  • Wisconsin
    • Amery, Wisconsin, United States, 54001
      • HRA Pharma Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

-Women who are willing purchase (in the pharmacies) or be provided (in the clinics) 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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 everyday for up to 16 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 16 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.; Other Names: Opill

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 Study prematuraly discontinued No Self-selection endpoint calculations were made.	Day One
Actual Use: Use of the Study Medication Every Day	Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made	Up to 16 weeks
Actual Use: Use of the Study Medication at the Same Time of Day	Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.	Up to 16 weeks
Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs	Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control.	Proportion of user population who do not use study medication together with another form of hormone-containing birth control. Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made	Up to 16 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	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 Study prematurely discontinued No Actual Use endpoint calculations were made	Up to 16 weeks
Proportion of Self-selection Population Taking One of the "Ask a Doctor or Pharmacist Before Use" Products Who do Not Select, Who Select But do Not Use, or Who Report Contacting a Healthcare Provider or Pharmacist About Use of the Product	Proportion of self-selection population taking one of the "ask a doctor or pharmacist before use" products who do not select, who select but do not use, or who report contacting a healthcare provider Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made	Up to 16 weeks
Proportion of Self-selection Population Who Report Having Liver Problems Who Either do Not Select ,Who Select But do Not Use, or Who Report Contacting a Healthcare Provider About Use of the Product.	Proportion of self-selection population who report having liver problems who either do not select ,who select but do not use, or who report contacting a healthcare provider about use of the product. Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made.	Up to 16 weeks
Proportion of User Population Who Experience One of the "Talk to a Doctor" Conditions Listed Within the "When Using This Product" or "Stop Use and Ask a Doctor" Sections	Proportion of user population who experience one of the "Talk to a doctor" conditions listed within the "When using this product" or "Stop use and ask a doctor" sections Measurement tool: phone interview Study prematurely discontinued No User endpoint calculations were made.	Up to 16 weeks
Safety Population: Number of Pregnancies Reported During the Course of the Study	Number of pregnancies reported during the course of the study Measurement tool: phone interview	Up to 16 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2018
• Primary Completion (Actual): September 9, 2018
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 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: 151042-001

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