Phase 3
N=1,270
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Emergency Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03208985 ↗Enrolled (actual)
1,270
Serious AEs
1.9%
Results posted
Dec 2022
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Use Phase (Ulipristal Acetate, 30 mg) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- HRA Pharma
- Primary completion
- Jun 2018
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 | — |
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.
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.