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

May 14, 2013 updated by: HRA Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Dept of Women & Child Health - Karolinska University Hospital
  • United Kingdom
      • Belfast, United Kingdom, BT12DX
        • Brook clinic
  • United States
    • Colorado
      • Denver, Colorado, United States, CO 80218
        • PPRM Central clinic
      • Lakewood, Colorado, United States, CO 80232
        • PPRM Southwest clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, PA 19107
        • Elizabeth Blackwell Health Center
      • Philadelphia, Pennsylvania, United States, PA19107
        • Locust Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adolescents
250 postmenarcheal adolescent girls
Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Names:
  • ellaOne®
Adults
250 adult women
Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Names:
  • ellaOne®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Two months (i.e. during two menstrual cycles following ellaOne® intake)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HRA Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2914-010
  • 2009-017771-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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