Eligibility, female only, with Emergency Contraception. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.Primary· 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.
Group
Value
95% CI
Use Phase (Ulipristal Acetate, 30 mg)
704
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.Primary· 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.
Group
Value
95% CI
Use Phase (Ulipristal Acetate, 30 mg)
712
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.Primary· 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.
Group
Value
95% CI
Self-Selection Population
814
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 6 weeks.
Reporting threshold: 0.1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other recruiting trials for Emergency Contraception
Currently open trials in the same condition.
NCT06162611 — Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
· Phase 4
· recruiting
Other HRA Pharma trials
Trials by the same sponsor.
NCT04112095 — Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
· Phase 3
· completed
NCT04872920 — Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.
· unknown
NCT03585712 — Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and Afte
· Phase 2
· completed
NCT03559010 — A Study of Oral Contraception Under Simulated OTC Conditions
· Phase 3
· terminated
NCT01569737 — Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HRA Pharma
Last refreshed: 2 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03208985.