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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01107106

Enrollment

579

Registered

2010-04-20

Start date

2010-05-31

Completion date

2013-02-28

Last updated

2013-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Contraceptive Methods, Female Contraception

Brief 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.

Interventions

DRUGellaOne® (ulipristal acetate)

one single oral dose (30 mg tablet)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception	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

Measure	Time frame
Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception	Two months (i.e. during two menstrual cycles following ellaOne® intake)

Countries

Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026