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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use Phase (Ulipristal Acetate, 30 mg) | Experimental | One tablet of 30 mg of ulipristal acetate for emergency contraception |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use Phase (Ulipristal Acetate, 30 mg) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russel Bradford, MD, MSPH | Pegus Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRA Pharma Investigational Site | Rancho Cucamonga | California | 91730 | United States | ||
| HRA Pharma Investigational Site |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2017 | Sep 12, 2022 |
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|
| Boulder |
| Colorado |
| 80302 |
| United States |
| HRA Pharma Investigational Site | Denver | Colorado | 80003 | United States |
| HRA Pharma Investigational Site | Denver | Colorado | 80207 | United States |
| HRA Pharma Investigational Site | Fort Myers | Florida | 33919 | United States |
| HRA Pharma Investigational Site | Miami | Florida | 33133 | United States |
| HRA Pharma Investigational Site | Orlando | Florida | 32817 | United States |
| HRA Pharma Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| HRA Pharma Investigational Site | St. Petersburg | Florida | 33701 | United States |
| HRA Pharma Investigational Site | Tampa | Florida | 33617 | United States |
| HRA Pharma Investigational Site | Belleville | Illinois | 62226 | United States |
| HRA Pharma Investigational Site | Andover | Minnesota | 55304 | United States |
| HRA Pharma Investigational Site | Saint Louis Park | Minnesota | 55426 | United States |
| HRA Pharma Investigational Site | City of Saint Peters | Missouri | 63376 | United States |
| HRA Pharma Investigational Site | Kansas City | Missouri | 64111 | United States |
| HRA Pharma Investigational Site | Manchester | Missouri | 63088 | United States |
| HRA Pharma Investigational Site | St Louis | Missouri | 63108 | United States |
| HRA Pharma Investigational Site | St Louis | Missouri | 63118 | United States |
| HRA Pharma Investigational Site | Las Vegas | Nevada | 89102 | United States |
| HRA Pharma Investigational Site | Hackensack | New Jersey | 07601 | United States |
| HRA Pharma Investigational Site | Morristown | New Jersey | 07960 | United States |
| HRA Pharma Investigational Site | New Brunswick | New Jersey | 08901 | United States |
| HRA Pharma Investigational Site | Trenton | New Jersey | 08608 | United States |
| HRA Pharma Investigational Site | Albuquerque | New Mexico | 87104 | United States |
| HRA Pharma Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| HRA Pharma Investigational Site | New York | New York | 10012 | United States |
| HRA Pharma Investigational Site | Durham | North Carolina | 27704 | United States |
| HRA Pharma Investigational Site | Raleigh | North Carolina | 27603 | United States |
| HRA Pharma Investigational Site | Portland | Oregon | 97212 | United States |
| HRA Pharma Investigational Site | Bremerton | Washington | 98310 | United States |
| HRA Pharma Investigational Site | Puyallup | Washington | 98373 | United States |
| HRA Pharma Investigational Site | Seattle | Washington | 98122 | United States |
| HRA Pharma Investigational Site | Seattle | Washington | 98133 | United States |
| HRA Pharma Investigational Site | Tacoma | Washington | 98405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Subjects who take at least one dose of study medication during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Literacy using REALM test pr REALM Teen test | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | User Population: subjects who have taken at least one dose of study medication during the study. | Posted | Number | Dosing instances 120 hrs of unprotec.sex | Up to 6 Weeks | All dosing instances | All dosing instances |
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|
| ||||||||||||||||||||||||||
| 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. | Posted | Number | Dosing no more than 1 tablet was taken | Up to 6 Weeks | All dosing instances | All dosing instances |
|
| ||||||||||||||||||||||||||||
| 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. | 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?' | Posted | Count of Participants | Participants | Day 1 |
|
|
up to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | 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. | 0 | 783 | 15 | 783 | 132 | 783 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exposure During Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Spontaneous abortions | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Volvulus of bowel | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Kidney infection | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Decreased appetite | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rash | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| Vaginal infection | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Exposure during breast feeding | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Laceration | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Trichomoniasis | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Urticaria | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine VENARD | HRA Pharma | +33184139244 | c.venard@hra-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2018 | Sep 12, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Literacy Unknown |
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| All dosing instances |
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