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A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions

NCT03208985 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1270

Last updated 2022-12-02

Study results available
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Summary

This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.

Conditions

  • Emergency Contraception

Interventions

DRUG

Use Phase (Ulipristal Acetate, 30 mg)

All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate. Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).

Sponsors & Collaborators

  • HRA Pharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2018-06-14
Completion
2018-06-14
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 NCT03208985 on ClinicalTrials.gov