Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women

Conditions
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Contraception

Intervention / Treatment
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* Drug: ellaOne® (ulipristal acetate)
* Drug: ellaOne® (ulipristal acetate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having received ellaOne® as emergency contraception at the clinical site Postmenarcheal adolescents or adult women Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery Able to provide written informed consent Willing to not participate in a clinical trial before the end of study participation Exclusion Criteria: Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents<br>250 postmenarcheal adolescent girls | Drug: ellaOne® (ulipristal acetate)<br>* one single oral dose (30 mg tablet)<br>* Other names: ellaOne®;|
| Adults<br>250 adult women | Drug: ellaOne® (ulipristal acetate)<br>* one single oral dose (30 mg tablet)<br>* Other names: ellaOne®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraceptive Methods, Female Contraception