Phase 3
Completed N=1,270
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Emergency Contraception
Source: ClinicalTrials.gov NCT03208985 ↗
Enrolled (actual)
1,270
Serious AEs
1.9%
Results posted
Dec 2022
Primary outcomePrimary: Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. — 704 Dosing instances 120 hrs of unprotec.sex
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. |
704 | — |
| PRIMARY Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken. |
712 | — |
| PRIMARY Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision. |
814 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03208985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.