Emergency Contraception
Conditions
Keywords
Emergency contraception
Brief 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.
Detailed description
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.
Interventions
DRUGUse 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).
Sponsors
HRA Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. | 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. |
| Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken. | 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. |
| Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Use Phase (Ulipristal Acetate, 30 mg) One tablet of 30 mg of ulipristal acetate for emergency contraception
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). | 681 |
| Total | 681 |
Baseline characteristics
| Characteristic | Use Phase (Ulipristal Acetate, 30 mg) |
|---|---|
| Age, Continuous | 26.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 173 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 506 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Literacy using REALM test pr REALM Teen test Literacy Unknown | 5 Participants |
| Literacy using REALM test pr REALM Teen test Low Literacy | 104 Participants |
| Literacy using REALM test pr REALM Teen test Normal Literacy | 572 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 224 Participants |
| Race (NIH/OMB) More than one race | 59 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 68 Participants |
| Race (NIH/OMB) White | 283 Participants |
| Region of Enrollment United States | 681 participants |
| Sex: Female, Male Female | 681 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 783 |
| other Total, other adverse events | 132 / 783 |
| serious Total, serious adverse events | 15 / 783 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Use Phase (Ulipristal Acetate, 30 mg) | Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken. | 712 Dosing no more than 1 tablet was taken |
Primary
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
Population: User Population: subjects who have taken at least one dose of study medication during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 Dosing instances 120 hrs of unprotec.sex |
Primary
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
Population: Subjects who accepted the invitation to participate and met study inclusion criteria, participated in a face-to-face interview at the study site and made a self-selection and purchase decision, have performed an enrollment pregnancy test and either have answered 'No' to the question 'Are you currently pregnant?'
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Use Phase (Ulipristal Acetate, 30 mg) | Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision. | 814 Participants |