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 |
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)
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4
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