The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,221
Single dose
Single dose
Number of Participants With Pregnancy
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Time frame: Within 72 hours of unprotected Intercourse
Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone \& Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.
Time frame: Within 120 hours of unprotected Intercourse
Menstrual Bleeding Patterns
Onset of next menses after emergency contraception compared to usual date.
Time frame: within the menstrual cycle of the unprotected Intercourse
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