Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03208985 | A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions | PHASE3 | COMPLETED | 1,270 | — | — | May 23, 2017 | Jun 14, 2018 | Dec 2, 2022 | 34 | United States |
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