Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
NCT ID: NCT01107106
Last Updated: 2013-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
579 participants
OBSERVATIONAL
2010-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Adolescents
250 postmenarcheal adolescent girls
ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Adults
250 adult women
ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Interventions
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ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
Yes
Sponsors
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HRA Pharma
INDUSTRY
Responsible Party
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Locations
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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, United States
Dept of Women & Child Health - Karolinska University Hospital
Stockholm, , Sweden
Brook clinic
Belfast, , United Kingdom
Countries
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Other Identifiers
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2009-017771-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2914-010
Identifier Type: -
Identifier Source: org_study_id
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