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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017771-21 | EudraCT Number |
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The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents | 250 postmenarcheal adolescent girls |
| |
| Adults | 250 adult women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ellaOne® (ulipristal acetate) | Drug | one single oral dose (30 mg tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception | Collection of adverse events, concomitant treatments, length of menstrual cycle, and vaginal bleeding/spotting through follow-up contacts and a diary completed by the patient | Two months (i.e. all along 2 menstrual cycles following ellaOne® intake) |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception | Two months (i.e. during two menstrual cycles following ellaOne® intake) |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPRM Central clinic | Denver | Colorado | CO 80218 | United States | ||
| PPRM Southwest clinic |
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| ellaOne® (ulipristal acetate) | Drug | one single oral dose (30 mg tablet) |
|
|
| Lakewood |
| Colorado |
| CO 80232 |
| United States |
| Elizabeth Blackwell Health Center | Philadelphia | Pennsylvania | PA 19107 | United States |
| Locust Health Center | Philadelphia | Pennsylvania | PA19107 | United States |
| Dept of Women & Child Health - Karolinska University Hospital | Stockholm | Sweden |
| Brook clinic | Belfast | BT12DX | United Kingdom |
| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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