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A Study of Oral Contraception Under Simulated OTC Conditions

NCT03559010 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2022-04-04

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • HRA Pharma

    lead INDUSTRY

Principal Investigators

  • Russell Bradford, MD, MSPH · Pegus Research, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2018-09-09
Completion
2018-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03559010 on ClinicalTrials.gov