CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,270 enrolled
Drug / intervention
Use Phase (Ulipristal Acetate, 30 mg)drug
Likely dose
Use Phase (Ulipristal Acetate, 30 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03208985
NCT03208985Phase 3Completed
CompareCT.gov

A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)

HRA Pharma·interventional·Posted Jul 6, 2017·Updated Dec 2, 2022

In Brief

A Phase 3 clinical trial evaluating Use Phase (Ulipristal Acetate, 30 mg) for Emergency Contraception. Completed, enrolled 1,270 participants across 34 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEmergency Contraception
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 6, 2017
Enrollment StartMay 23, 2017
Primary CompletionJun 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.0 years ago

Interventions

Use Phase (Ulipristal Acetate, 30 mg)drug

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).