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

April 12, 2010
May 14, 2013
May 2010
January 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01107106 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Contraception
Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Name: ellaOne®
  • Adolescents
    250 postmenarcheal adolescent girls
    Intervention: Drug: ellaOne® (ulipristal acetate)
  • Adults
    250 adult women
    Intervention: Drug: ellaOne® (ulipristal acetate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
579
February 2013
January 2013   (final data collection date for primary outcome measure)

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)
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Sweden,   United Kingdom
 
NCT01107106
2914-010, 2009-017771-21
No
HRA Pharma
HRA Pharma
Not Provided
Not Provided
HRA Pharma
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP