A Study of Oral Contraception Under Simulated OTC Conditions

Contraception Clinical Trial

— OPTION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03559010
• Other study ID #: 151042-001
• Status: Terminated
• Phase: Phase 3
• Start date: April 27, 2018
• Est. completion date: November 14, 2018

Study information

• Verified date: March 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 189
• Est. completion date: November 14, 2018
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

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 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.

Locations

Country	Name	City	State
United States	HRA Pharma Investigational site	Albuquerque	New Mexico
United States	HRA Pharma Investigational site	Albuquerque	New Mexico
United States	HRA Pharma Investigational site	Albuquerque	New Mexico
United States	HRA Pharma Investigational site	Amery	Wisconsin
United States	HRA Pharma Investigational site	Anoka	Minnesota
United States	HRA Pharma Investigational site	Bethlehem	Pennsylvania
United States	HRA Pharma Investigational site	Birmingham	Alabama
United States	HRA Investigational site	Bountiful	Utah
United States	HRA Pharma Investigational site	Bridgeport	Connecticut
United States	HRA Pharma Investigational site	Burlington	North Carolina
United States	HRA Pharma Investigational site	Catonsville	Maryland
United States	HRA Pharma Investigational site	Clarksville	Tennessee
United States	HRA Pharma Investigational site	Cleveland	Tennessee
United States	HRA Pharma Investigational site	Dalton	Georgia
United States	HRA Pharma Investigational site	Downey	California
United States	HRA Pharma Investigational site	Elk River	Minnesota
United States	HRA Pharma Investigational site	Elsberry	Missouri
United States	HRA Pharma Investigational site	Enumclaw	Washington
United States	HRA Pharma Investigational site	Fridley	Minnesota
United States	HRA Pharma Investigational site	Griffin	Georgia
United States	HRA Pharma Investigational site	Hartford	Connecticut
United States	HRA Pharma Investigational site	Homewood	Alabama
United States	HRA Pharma Investigational site	Houston	Texas
United States	HRA Pharma Investigational site	Houston	Texas
United States	HRA Pharma Investigational site	Kenmore	Washington
United States	HRA Pharma Investigational site	La Habra	California
United States	HRA Pharma Investigational site	Long Beach	California
United States	HRA Pharma Investigational site	Los Angeles	California
United States	HRA Pharma Investigational site	Manchester	Missouri
United States	HRA Pharma Investigational site	Mapleton	Utah
United States	HRA Pharma Investigational site	McCalla	Alabama
United States	HRA Pharma Investigational site	Monroe	New Jersey
United States	HRA Pharma Investigational site	Montpelier	Virginia
United States	HRA Pharma Investigational site	New Haven	Connecticut
United States	HRA Pharma Investigational site	Riverview	Florida
United States	HRA Pharma Investigational Site	Saint Francis	Minnesota
United States	HRA Pharma Investigational Site	Savannah	Missouri
United States	HRA Pharma Investigational site	Seattle	Washington
United States	HRA Pharma Investigational site	Sherman	Texas
United States	HRA Pharma Investigational site	Snohomish	Washington
United States	HRA Pharma Investigational Site	South Charleston	Ohio
United States	HRA Pharma Investigational site	Springfield	Missouri
United States	HRA Pharma Investigational site	Syracuse	Utah
United States	HRA Pharma Investigational site	Tucson	Arizona

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 Study prematuraly discontinued No Self-selection endpoint calculations were made.	Day One
Primary	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
Primary	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
Primary	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	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
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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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