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The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ella |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ella | Drug | ella, single intake, tablet 30mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Assessed Pregnancy Outcomes | Live birth outcomes: Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age; Pregnancy loss outcomes: Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation); Fetal death: Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation); Induced abortions can be either: An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications) | up to 9 months after pregnancy diagnosis |
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Pregnant women who have been exposed to ella during the menstrual cycle in which the pregnancy started or at any time during pregnancy will be enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Fine, MD | Planned Parenthood Gulf Coast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Federation of America, Inc | New York | New York | 10001 | United States |
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Ella-exposed pregnant women were recruited either by Health Care Professionals at Family Planning Clinics or through web-based self enrollment between November 2014 and December 2017.
The first participant was enrolled on November 18, 2014 and the last participant was enrolled December 12, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ella | ella: ella, single intake, tablet 30mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ella | ella: ella, single intake, tablet 30mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Outcome was not known for 3 patients, thus not included in the Analysis population. |
| 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 | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Live birth outcomes: Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age; Pregnancy loss outcomes: Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation); Fetal death: Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation); Induced abortions can be either: An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications) | Pregnancy outcomes were described for pregnancies with known outcome (patients with missing outcomes and patients lost to follow-up were excluded from the descriptive analyses). | Posted | Count of Participants | Participants | up to 9 months after pregnancy diagnosis |
Adverse events were not collected in the context of this Phase IV observational study.
When applicable, Individual Case Safety Reports were reported to Health Authorities on an expedited basis according to current regulation (no later than 15 calendar days from receipt).
Unintended pregnancy reports (i.e. reports of pregnancies inadvertently exposed to ella without outcome data or with normal outcome) are considered as not serious by the company.
Reports of the aggregate data concerning pregnancies were compiled and submitted to Health Authorities via PSUR.
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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 | Ella | ella: ella, single intake, tablet 30mg | 0 |
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This was an observational study only, thus we were limited to the outcomes reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Adelbrecht, Clinical Trial Coordinator | HRA Pharma | +33 1 40 33 32 74 | c.adelbrecht@hra-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2016 | Jul 22, 2019 | SAP_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 30, 2015 | Sep 26, 2019 | Prot_ICF_001.pdf |
| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Analysis includes all patients for whom values were known. | Mean | Standard Deviation | kg/m^2 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ella | ella: ella, single intake, tablet 30mg |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
In accordance with the Study protocol signed by the PI, (i) sponsor owns the study data (ii) HCP agrees that the results of the study may be used for the purposes of publications, and information for medical and pharmaceutical professionals (iii) if sponsor publishes the study results within 24-month, PI may elect to serve as co-authors, and following publication, will be permitted to present the results of such publications in symposia.