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

NCT04112095 | Completed Phase 3 FDA Drug

• 1 other identifier: 151042-004
• Study Type: interventional
• Target: 962
• Locations: 1 country
• Sites: 38

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.

Conditions

Contraception

Keywords

Daily birth control

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product.

  One Day

• Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors.

  Up to 24 Weeks

• Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors.

  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.

  Up to 24 Weeks

• Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.

  Up to 24 Weeks

Study Arms (1)

Use Phase Norgestrel 0.075 mg

EXPERIMENTAL

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

Interventions

Norgestrel 0.075 mg tablets DRUG

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.

Use Phase Norgestrel 0.075 mg

Eligibility Criteria

• Age: 11 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cannot read, speak and understand English
• Cannot see well enough to read information on the label

Sponsors & Collaborators

• HRA Pharma: lead

Study Sites (38)

HRA Pharma Investigational site 1012

Birmingham, Alabama, 35215, United States

Location

HRA Pharma Investigational Site 1008

Homewood, Alabama, 35209, United States

Location

HRA Pharma Investigational Site 1038

Mesa, Arizona, 85203, United States

Location

HRA Pharma Investigational Site 1032

Phoenix, Arizona, 85021, United States

Location

HRA Pharma Investigational Site 1027

Cerritos, California, 90703, United States

Location

HRA Pharma Investigational Site 1039

Downey, California, 90242, United States

Location

HRA Pharma investigational site 1035

Long Beach, California, 90806, United States

Location

HRA Pharma Investigational Site 1017

Long Beach, California, 90815, United States

Location

HRA Pharma Investigational Site 1034

Los Angeles, California, 90005, United States

Location

HRA Pharma Investigational Site 1029

Los Angeles, California, 90036, United States

Location

HRA Pharma Investigational Site 1028

Los Angeles, California, 90057, United States

Location

HRA Pharma Investigational Site 1033

Aurora, Colorado, 80045, United States

Location

HRA Pharma Investigational Site 1023

Dalton, Georgia, 30721, United States

Location

HRA Pharma Investigational Site 1018

Griffin, Georgia, 30224, United States

Location

HRA Pharma Investigational Site 1014

Rosedale, Maryland, 21237, United States

Location

HRA Pharma Investigational Site 1019

Framingham, Massachusetts, 01702, United States

Location

HRA Pharma Investigational Site 1011

Andover, Minnesota, 55304, United States

Location

HRA Pharma Investigational Site 1006

Elk River, Minnesota, 55330, United States

Location

HRA Pharma Investigational Site 1003

Saint Francis, Minnesota, 55070, United States

Location

HRA Pharma Investigational Site 1020

Saint Louis Park, Minnesota, 55426, United States

Location

HRA Pharma Investigational Site 1009

Albuquerque, New Mexico, 87104, United States

Location

HRA Pharma Investigational Site 1007

Albuquerque, New Mexico, 97110, United States

Location

HRA Pharma Investigational Site 1030

Bronxville, New York, 10708, United States

Location

HRA Pharma Investigational Site 1013

New York, New York, 10034, United States

Location

HRA Pharma Investigational Site 1037

The Bronx, New York, 10463, United States

Location

HRA Pharma Investigational Site 1031

The Bronx, New York, 10467, United States

Location

HRA Pharma Investigational Site 1015

Burlington, North Carolina, 27215, United States

Location

HRA Pharma Investigational Site 1002

South Charleston, Ohio, 45368, United States

Location

HRA Pharma Investigational Site 1036

Lafayette Hill, Pennsylvania, 19444, United States

Location

HRA Pharma Investigational Site 1025

Philadelphia, Pennsylvania, 19136, United States

Location

HRA Pharma investigational site 1016

Clarksville, Tennessee, 37043, United States

Location

HRA Pharma Investigational Site 1022

Houston, Texas, 77008, United States

Location

HRA Pharma Investigational Site 1001

Houston, Texas, 77099, United States

Location

HRA Pharma investigational site 1024

Mapleton, Utah, 84664, United States

Location

HRA Pharma Investigational Site 1040

Salt Lake City, Utah, 84101, United States

Location

HRA Pharma Investigational Site 1021

Enumclaw, Washington, 98022, United States

Location

HRA Pharma Investigational site 1005

Seattle, Washington, 98117, United States

Location

HRA Pharma Investigational site 1010

Snohomish, Washington, 98290, United States

Location

MeSH Terms

Interventions

Norgestrel

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Russ Bradford, MD, MSPH

  Pegus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: September 6, 2019
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)