Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,270

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2017

Shorter than P25 for phase_3

Geographic Reach

1 country

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

May 23, 2017

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed

4.5 years until next milestone

Results Posted

Study results publicly available

December 2, 2022

Completed

Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

June 26, 2017

Results QC Date

September 22, 2022

Last Update Submit

November 16, 2022

Conditions

Emergency Contraception

Keywords

Emergency contraception

Outcome Measures

Primary Outcomes (3)

Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
The first primary endpoint is the proportion in which the denominator includes all dosing instances of the IP and the numerator includes all dosing instances of the IP which were taken within 120 hours (5 days) of the subject's most recent episode of unprotected sex.
Up to 6 Weeks
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
The second primary endpoint is the proportion in which the denominator is all discrete dosing instances of the IP and the numerator includes all dosing instances where no more than one tablet was taken.
Up to 6 Weeks
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
The third primary endpoint is the proportion in which the denominator includes all females who selected to use the product (regardless of whether they purchased/used) and the numerator includes all female selectors who were not pregnant at the time of the selection decision.
Day 1

Study Arms (1)

Use Phase (Ulipristal Acetate, 30 mg)

EXPERIMENTAL

One tablet of 30 mg of ulipristal acetate for emergency contraception

Drug: Use Phase (Ulipristal Acetate, 30 mg)

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).

Use Phase (Ulipristal Acetate, 30 mg)

Eligibility Criteria

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Women who are self-pay or who are willing to be self-pay for the purposes of the study and who present for emergency contraception only for their own use

You may not qualify if:

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

Contact the study team to confirm eligibility.