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

Completed

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT01107106

Run by

HRA Pharma

People needed

579

Starts

2010-05-01

Expected to finish

2013-02-01

Last updated by the study team

2013-05-15

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)

Where it is running

• PPRM Central clinic — Denver, Colorado, United States
• PPRM Southwest clinic — Lakewood, Colorado, United States
• Elizabeth Blackwell Health Center — Philadelphia, Pennsylvania, United States
• Locust Health Center — Philadelphia, Pennsylvania, United States
• Dept of Women & Child Health - Karolinska University Hospital — Stockholm, Sweden
• Brook clinic — Belfast, United Kingdom

Full record on ClinicalTrials.gov

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