A Phase 3 interventional study of Use Phase (Ulipristal Acetate, 30 mg) in Emergency Contraception, sponsored by HRA Pharma. Completed at 34 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by HRA Pharma · Phase 3, Interventional, and Other
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.
All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.
Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 1,270 is above the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →HRA Pharma is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One tablet of 30 mg of ulipristal acetate for emergency contraception
Drug: Use Phase (Ulipristal Acetate, 30 mg)
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).
Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
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.
Time frame: Up to 6 Weeks
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
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.
Time frame: Up to 6 Weeks
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
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.
Time frame: Day 1
In order to be as representative as possible of the OTC EC-seeking population, when potential subjects came to a site looking to purchase EC, they've been offered the opportunity to participate in the study. If approximately 75% of subjects pass the screening criteria, self-select and both qualify and agree to purchase and enter the use phase, it was expected that up to 1270 subjects will need to be interviewed to yield 950 purchasers and 760 in use population.
| Milestone | Self-Selection Population |
|---|---|
| Started | 1270 |
| Completed | 868 |
| Not completed | 402 |
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.
| Dosing instances 120 hrs of unprotec.sex | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. | 704 |
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.
| Dosing no more than 1 tablet was taken | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken. | 712 |
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.
| Participants | Self-Selection Population |
|---|---|
| Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision. | 814 |
Collected over up to 6 weeks. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Population | 0/783 (0%) | 15/783 (1.9%) | 132/783 (16.9%) |
| Event | Safety Population |
|---|---|
| Exposure During PregnancyPregnancy, puerperium and perinatal conditions | 11/783 |
| Spontaneous abortionsPregnancy, puerperium and perinatal conditions | 2/783 |
| Volvulus of bowelGastrointestinal disorders | 1/783 |
| Kidney infectionRenal and urinary disorders | 1/783 |
| Allergic reactionImmune system disorders | 1/783 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/783 |
| Event | Safety Population |
|---|---|
| Abdominal pain lowerGastrointestinal disorders | 23/783 |
| NauseaGastrointestinal disorders | 13/783 |
| FatigueGeneral disorders | 9/783 |
| Urinary tract infectionRenal and urinary disorders | 9/783 |
| Viral upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 9/783 |
| Abdominal painGastrointestinal disorders | 5/783 |
| HeadacheGeneral disorders | 5/783 |
| InfluenzaImmune system disorders | 5/783 |
| Bacterial vaginosisInfections and infestations | 4/783 |
| Decreased appetiteGastrointestinal disorders | 4/783 |
Subjects who take at least one dose of study medication during the study.
| Age, Continuous(years) | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Median | 26.4 (14 to 50) |
| Sex: Female, Male(Participants) | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Female | 681 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Hispanic or Latino | 173 |
| Not Hispanic or Latino | 506 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| American Indian or Alaska Native | 7 |
| Asian | 31 |
| Native Hawaiian or Other Pacific Islander | 9 |
| Black or African American | 224 |
| White | 283 |
| More than one race | 59 |
| Unknown or Not Reported | 68 |
| Region of Enrollment(participants) | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| United States | 681 |
| Literacy using REALM test pr REALM Teen test(Participants) | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Normal Literacy | 572 |
| Low Literacy | 104 |
| Literacy Unknown | 5 |
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HRA Pharma