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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107106
• Other study ID #: 2914-010
• Secondary ID: 2009-017771-21
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: May 14, 2013
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardUK: Multicentre Research Ethics CommitteeFrance: CCTIRS, CNOM, CNILUnited States: Food and Drug AdministrationGermany: Bfarm, KBV
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
• ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)

Locations

Country	Name	City	State
Sweden	Dept of Women & Child Health - Karolinska University Hospital	Stockholm
United Kingdom	Brook clinic	Belfast
United States	PPRM Central clinic	Denver	Colorado
United States	PPRM Southwest clinic	Lakewood	Colorado
United States	Elizabeth Blackwell Health Center	Philadelphia	Pennsylvania
United States	Locust Health Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Countries where clinical trial is conducted

United States,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception	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	Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)	Yes
Secondary	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)	No