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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HRA Pharma
ClinicalTrials.gov Identifier:
NCT01107106
First received: April 12, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Contraception
 Drug: ellaOne® (ulipristal acetate)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 579
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescents
250 postmenarcheal adolescent girls
 Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Name: ellaOne®
Adults
250 adult women
 Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Name: ellaOne®

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107106

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

No publications provided

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01107106     History of Changes
Other Study ID Numbers: 2914-010, 2009-017771-21
Study First Received: April 12, 2010
Last Updated: May 14, 2013
Health Authority: Sweden: Regional Ethical Review Board
UK: Multicentre Research Ethics Committee
France: CCTIRS, CNOM, CNIL
United States: Food and Drug Administration
Germany: Bfarm, KBV

Keywords provided by HRA Pharma:
Contraceptive Methods
Female Contraception

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013