Clinical Studies

TOPICS CLINICAL STUDY METHODOLOGY SAMPLE MESSAGE AND RESULTS
DEFINITION OF THE PROBLEM Wilcox1 Prospective cohort study 221 healthy women who were planning a pregnancy The timing of their fertile window can be highly unpredictable so unprotected sex carries a risk at any time1
MECHANISM OF ACTION Brache2 Analysis of pooled data from three randomised trials of emergency contraception regimes2 163 women2 1° UPA postpones ovulation2
2° UPA delays ovulation for at least 5 days in a higher proportion of women than LNG  (p=0.0001) even when given in the advance follicular phase2
EFFICACY Creinin3 Randomised, double blind, comparative study of UPA vs LNG contraception with pregnancy as a primary outcome measure3 1546 women3 UPA is at least as effective as LNG in preventing pregnancies3,4
Glasier4 Randomised single blind comparative EC trial of UPA vs LNG4 1696 women received EC within 72h of sexual intercourse4
Glasier4, Crenin Pooled analysis4 3445 women4 More pregnancies are prevented with UPA than LNG when taken in the first 72h (p=0.046)4
SAFETY Glasier4 Randomised single blind comparative EC trial of UPA vs LNG4 1696 women received EC within 72h of sexual intercourse4 UPA is well tolerated in more than 1000 women treated. Similar adverse event profile as LNG3

 


References
1.Wilcox AJ et al. BMJ 2000; 321: 1259-62.
2.Brache V et al. Contraception 2013; 88(5): 611-618.
3.Creinin M et al. Obstet Gynecol 2006; 108(5): 1089–1097.

4.Glasier AF et al. The Lancet 2010; 375: 555-562.