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
Philadelphia, Pennsylvania 19107
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Denver, Colorado 80218
817
mi
from 91732
Denver, CO
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Lakewood, Colorado 80232
812
mi
from 91732
Lakewood, CO
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials