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

All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.

Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.

• 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).

Primary outcomes

• Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. [Up to 6 Weeks]: 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.
• Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken. [Up to 6 Weeks]: 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.
• Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision. [Day 1]: 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.

Sex: Female, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Participant flow

Outcome results

• Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. (Primary), Number, Dosing instances 120 hrs of unprotec.sex: Use Phase (Ulipristal Acetate, 30 mg) 704
• Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken. (Primary), Number, Dosing no more than 1 tablet was taken: Use Phase (Ulipristal Acetate, 30 mg) 712
• Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision. (Primary), Count of participants, Participants: Self-Selection Population 814

Adverse events

Time frame: up to 6 weeks

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2017-05-16)
• Statistical Analysis Plan (PDF, 2018-11-16)

• Russel Bradford, MD, MSPH, Principal investigator, Pegus Research, Inc.