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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HRA Pharma
• Treatments: Ulipristal acetate

Criteria

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)