Clinical trial NCT03559010: A Study of Oral Contraception Under Simulated OTC Conditions
Official title: A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Contraception
Keywords: Daily birth control
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 189
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-selection
timeFrame: Day One
measure: Actual Use: Use of the Study Medication Every Day
timeFrame: Up to 16 weeks
measure: Actual Use: Use of the Study Medication at the Same Time of Day
timeFrame: Up to 16 weeks
measure: Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs
timeFrame: Up to 16 weeks
Secondary outcomes:
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 16 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: Up to 16 weeks
measure: 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
timeFrame: Up to 16 weeks
measure: 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.
timeFrame: Up to 16 weeks
measure: 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
timeFrame: Up to 16 weeks
measure: Safety Population: Number of Pregnancies Reported During the Course of the Study
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: HRA Pharma Investigational site
state: Alabama
city: Homewood
country: United States
facility: HRA Pharma Investigational site
state: Alabama
city: McCalla
country: United States
facility: HRA Pharma Investigational site
state: Alabama
city: Tucson
country: United States
facility: HRA Pharma Investigational site
state: Arizona
city: Downey
country: United States
facility: HRA Pharma Investigational site
state: California
city: La Habra
country: United States
facility: HRA Pharma Investigational site
state: California
city: Long Beach
country: United States
facility: HRA Pharma Investigational site
state: California
city: Los Angeles
country: United States
facility: HRA Pharma Investigational site
state: California
city: Bridgeport
country: United States
facility: HRA Pharma Investigational site
state: Connecticut
city: Hartford
country: United States
facility: HRA Pharma Investigational site
state: Connecticut
city: New Haven
country: United States
facility: HRA Pharma Investigational site
state: Connecticut
city: Riverview
country: United States
facility: HRA Pharma Investigational site
state: Florida
city: Dalton
country: United States
facility: HRA Pharma Investigational site
state: Georgia
city: Griffin
country: United States
facility: HRA Pharma Investigational site
state: Georgia
city: Catonsville
country: United States
facility: HRA Pharma Investigational site
state: Maryland
city: Anoka
country: United States
facility: HRA Pharma Investigational site
state: Minnesota
city: Elk River
country: United States
facility: HRA Pharma Investigational site
state: Minnesota
city: Fridley
country: United States
facility: HRA Pharma Investigational site
state: Minnesota
city: Saint Francis
country: United States
facility: HRA Pharma Investigational Site
state: Minnesota
city: Elsberry
country: United States
facility: HRA Pharma Investigational site
state: Missouri
city: Manchester
country: United States
facility: HRA Pharma Investigational site
state: Missouri
city: Savannah
country: United States
facility: HRA Pharma Investigational Site
state: Missouri
city: Springfield
country: United States
facility: HRA Pharma Investigational site
state: Missouri
city: Monroe
country: United States
facility: HRA Pharma Investigational site
state: New Jersey
city: Albuquerque
country: United States
facility: HRA Pharma Investigational site
state: New Mexico
city: Albuquerque
country: United States
facility: HRA Pharma Investigational site
state: New Mexico
city: Albuquerque
country: United States
facility: HRA Pharma Investigational site
state: New Mexico
city: Burlington
country: United States
facility: HRA Pharma Investigational site
state: North Carolina
city: South Charleston
country: United States
facility: HRA Pharma Investigational Site
state: Ohio
city: Bethlehem
country: United States
facility: HRA Pharma Investigational site
state: Pennsylvania
city: Clarksville
country: United States
facility: HRA Pharma Investigational site
state: Tennessee
city: Cleveland
country: United States
facility: HRA Pharma Investigational site
state: Tennessee
city: Houston
country: United States
facility: HRA Pharma Investigational site
state: Texas
city: Houston
country: United States
facility: HRA Pharma Investigational site
state: Texas
city: Sherman
country: United States
facility: HRA Pharma Investigational site
state: Texas
city: Bountiful
country: United States
facility: HRA Investigational site
state: Utah
city: Mapleton
country: United States
facility: HRA Pharma Investigational site
state: Utah
city: Syracuse
country: United States
facility: HRA Pharma Investigational site
state: Utah
city: Montpelier
country: United States
facility: HRA Pharma Investigational site
state: Virginia
city: Enumclaw
country: United States
facility: HRA Pharma Investigational site
state: Washington
city: Kenmore
country: United States
facility: HRA Pharma Investigational site
state: Washington
city: Seattle
country: United States
facility: HRA Pharma Investigational site
state: Washington
city: Snohomish
country: United States
facility: HRA Pharma Investigational site
state: Washington
city: Amery
country: United States
facility: HRA Pharma Investigational site
state: Wisconsin
Study officials:
affiliation: Pegus Research, Inc.
name: Russell Bradford, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: