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



Status:Recruiting
Conditions:Contraception, Contraception, Hospital
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:Any
Updated:3/30/2013
Start Date:May 2010
Contact:Kristina Gemzell-Danielsson, MD, PhD
Email:Kristina.Gemzell@ki.se
Phone:+46851772128

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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


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.


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)
We found this trial at
4
sites
Denver, Colorado 80218
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Lakewood, Colorado 80232
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Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19107
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