Trial Outcomes & Findings for A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions (NCT NCT03208985)
NCT ID: NCT03208985
Last Updated: 2022-12-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1270 participants
Primary outcome timeframe
Up to 6 Weeks
Results posted on
2022-12-02
Participant Flow
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.
Participant milestones
| Measure |
Self-Selection Population
Subjects who accept the invitation to participate and meet study inclusion criteria, participate in a face-to-face interview at the study site and make a self-selection and purchase decision
|
|---|---|
|
Overall Study
STARTED
|
1270
|
|
Overall Study
COMPLETED
|
868
|
|
Overall Study
NOT COMPLETED
|
402
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Baseline characteristics by cohort
| Measure |
Use Phase (Ulipristal Acetate, 30 mg)
n=681 Participants
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).
|
|---|---|
|
Age, Continuous
|
26.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
681 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
506 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
224 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
283 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
681 participants
n=5 Participants
|
|
Literacy using REALM test pr REALM Teen test
Normal Literacy
|
572 Participants
n=5 Participants
|
|
Literacy using REALM test pr REALM Teen test
Low Literacy
|
104 Participants
n=5 Participants
|
|
Literacy using REALM test pr REALM Teen test
Literacy Unknown
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 WeeksPopulation: User Population: subjects who have taken at least one dose of study medication during the study.
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.
Outcome measures
| Measure |
Use Phase (Ulipristal Acetate, 30 mg)
n=712 All dosing instances
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).
|
|---|---|
|
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 outcome
Timeframe: Up to 6 WeeksThe 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.
Outcome measures
| Measure |
Use Phase (Ulipristal Acetate, 30 mg)
n=712 All dosing instances
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).
|
|---|---|
|
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 outcome
Timeframe: Day 1Population: 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?'
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.
Outcome measures
| Measure |
Use Phase (Ulipristal Acetate, 30 mg)
n=819 Participants
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).
|
|---|---|
|
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
|
814 Participants
|
Adverse Events
Safety Population
Serious events: 15 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=783 participants at risk
A safety populationwas added as an analysis population, as adverse events are reportable from the time a subject signed informed consent and should thus not only be based on the user population.
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Exposure During Pregnancy
|
1.4%
11/783 • Number of events 11 • up to 6 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortions
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Gastrointestinal disorders
Volvulus of bowel
|
0.13%
1/783 • Number of events 1 • up to 6 weeks
|
|
Renal and urinary disorders
Kidney infection
|
0.13%
1/783 • Number of events 1 • up to 6 weeks
|
|
Immune system disorders
Allergic reaction
|
0.13%
1/783 • Number of events 1 • up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.13%
1/783 • Number of events 1 • up to 6 weeks
|
Other adverse events
| Measure |
Safety Population
n=783 participants at risk
A safety populationwas added as an analysis population, as adverse events are reportable from the time a subject signed informed consent and should thus not only be based on the user population.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.9%
23/783 • Number of events 23 • up to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.7%
13/783 • Number of events 13 • up to 6 weeks
|
|
General disorders
Fatigue
|
1.1%
9/783 • Number of events 9 • up to 6 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
1.1%
9/783 • Number of events 9 • up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
1.1%
9/783 • Number of events 9 • up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
5/783 • Number of events 5 • up to 6 weeks
|
|
General disorders
Headache
|
0.64%
5/783 • Number of events 5 • up to 6 weeks
|
|
Immune system disorders
Influenza
|
0.64%
5/783 • Number of events 5 • up to 6 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
0.51%
4/783 • Number of events 4 • up to 6 weeks
|
|
Gastrointestinal disorders
Decreased appetite
|
0.51%
4/783 • Number of events 4 • up to 6 weeks
|
|
Immune system disorders
Rash
|
0.51%
4/783 • Number of events 4 • up to 6 weeks
|
|
Renal and urinary disorders
Vaginal infection
|
0.51%
4/783 • Number of events 4 • up to 6 weeks
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.38%
3/783 • Number of events 3 • up to 6 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.38%
3/783 • Number of events 3 • up to 6 weeks
|
|
Injury, poisoning and procedural complications
Exposure during breast feeding
|
0.38%
3/783 • Number of events 3 • up to 6 weeks
|
|
Psychiatric disorders
Laceration
|
0.38%
3/783 • Number of events 3 • up to 6 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.38%
3/783 • Number of events 3 • up to 6 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Infections and infestations
Bronchitis
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Ear and labyrinth disorders
Dizziness
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.13%
1/783 • Number of events 2 • up to 6 weeks
|
|
Infections and infestations
Sinusitis
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Infections and infestations
Tooth infection
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Psychiatric disorders
Trichomoniasis
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Immune system disorders
Urticaria
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Metabolism and nutrition disorders
Vomiting
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal mycotic infection
|
0.26%
2/783 • Number of events 2 • up to 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place