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

Tracking Information
First Received Date ^ICMJE	April 12, 2010
Last Updated Date	May 14, 2013
Start Date ^ICMJE	May 2010
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 19, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01107106 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 19, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
Official Title ^ICMJE	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
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden
Condition ^ICMJE	Contraception
Intervention ^ICMJE	Drug: ellaOne® (ulipristal acetate) one single oral dose (30 mg tablet) Other Name: ellaOne®
Study Group/Cohort (s)	Adolescents 250 postmenarcheal adolescent girls Intervention: Drug: ellaOne® (ulipristal acetate) Adults 250 adult women Intervention: Drug: ellaOne® (ulipristal acetate)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	579
Completion Date	February 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01107106
Other Study ID Numbers ^ICMJE	2914-010, 2009-017771-21
Has Data Monitoring Committee	No
Responsible Party	HRA Pharma
Study Sponsor ^ICMJE	HRA Pharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	HRA Pharma
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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