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

HRA Pharma

Status: Completed

Conditions: Contraception

Treatments: Drug: ellaOne® (ulipristal acetate)

Study type: Observational

Funder types: Industry

Identifiers

NCT01107106

2914-010

2009-017771-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 579 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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)

Trial design

579 participants in 2 patient groups

Adolescents

Description:

250 postmenarcheal adolescent girls

Treatment:

Drug: ellaOne® (ulipristal acetate)

Drug: ellaOne® (ulipristal acetate)

Adults

Description:

250 adult women

Treatment:

Drug: ellaOne® (ulipristal acetate)

Drug: ellaOne® (ulipristal acetate)