Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Use Phase · 1 trial · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Use Phase (Ulipristal Acetate, 30 mg) | EXPERIMENTAL | One tablet of 30 mg of ulipristal acetate for emergency contraception |
| Name | Type | Description |
|---|---|---|
| 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). |
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
Use Phase is an investigational small molecule being developed for emergency contraception. It is currently in Phase 3 clinical development. The drug is intended for use as an emergency contraceptive, and it is being studied under simulated over-the-counter conditions to assess its potential for nonprescription use.
Use Phase is being developed by Perrigo Company plc, a company publicly traded under the ticker symbol PRGO. Perrigo is advancing the drug through clinical development for the indication of emergency contraception.
Use Phase is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 program includes a completed study that evaluated the drug under simulated over-the-counter conditions for emergency contraception.
Use Phase has one completed Phase 3 clinical trial, registered as NCT03208985. The study, titled 'A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions,' enrolled 1,270 female participants in the United States. The trial was uncontrolled and not blinded.
Yes, Use Phase is the same as Ella, an emergency contraceptive. The Phase 3 clinical trial NCT03208985 explicitly refers to 'Use of Ella®' in its title, confirming that Use Phase is the brand name Ella. The study evaluated Ella under simulated over-the-counter conditions.