Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
Information source: HRA Pharma
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: ellaOne® (ulipristal acetate) (Drug); ellaOne® (ulipristal acetate) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: HRA Pharma Overall contact:
Kristina Gemzell-Danielsson, MD, PhD, Phone: +46851772128, Email: Kristina.Gemzell@ki.se
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.
Clinical Details
Official title: 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
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
Secondary outcome: Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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)
Locations and Contacts
Kristina Gemzell-Danielsson, MD, PhD, Phone: +46851772128, Email: Kristina.Gemzell@ki.se
Dept of Women & Child Health - Karolinska University Hospital, Stockholm, Sweden; Not yet recruiting
Kristina Gemzell, Phone: +46851772128, Email: Kristina.Gemzell@ki.se
Kristina Gemzell-Danielsson, MD, PhD, Principal Investigator
Brook clinic, Belfast BT12DX, United Kingdom; Recruiting
Caroline Hunter, MD, Phone: +442 890 328 866, Email: carolinehunter@aol.co.uk
Caroline Hunter, MD, Principal Investigator
PPRM Central clinic, Denver, Colorado CO 80218, United States; Recruiting
Savita Ginde, MD, Email: Savita.ginde@pprm.org
PPRM Southwest clinic, Lakewood, Colorado CO 80232, United States; Recruiting
Savita Ginde, MD, Email: Savita.ginde@pprm.org
Savita Ginde, MD, Principal Investigator
Locust Health Center, Philadelphia, Pennsylvania PA19107, United States; Recruiting
Joel Lebed, MD, Email: joel.lebed@ppsp.org
Joel Lebed, MD, Principal Investigator
Elizabeth Blackwell Health Center, Philadelphia, Pennsylvania PA 19107, United States; Recruiting
Joel Lebed, MD
Joel Lebed, MD, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: March 29, 2012
|
