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 Type
OBSERVATIONAL
Enrollment
579
one single oral dose (30 mg tablet)
one single oral dose (30 mg tablet)
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
Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
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
Time frame: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)
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)
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Dept of Women & Child Health - Karolinska University Hospital
Stockholm, Sweden
Brook clinic
Belfast, United Kingdom