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

Completed

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Key information

Conditions

Contraception

Sex eligibility

Female

Study type

Observational

Primary location

Dept of Women & Child Health - Karolinska University Hospital, Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ellaOne® (ulipristal acetate)

Drug

one single oral dose (30 mg tablet)

Other names: ellaOne®

Primary outcomes

Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception

Time frame: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)

Collection of adverse events, concomitant treatments, length of menstrual cycle, and vaginal bleeding/spotting through follow-up contacts and a diary completed by the patient

Secondary outcomes

Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception

Time frame: Two months (i.e. during two menstrual cycles following ellaOne® intake)

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Apr 20, 2010
Registry last updated: May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed