V.N.Prilepskaya, А.А.Kuzemin, Т.А.Nazarenko, Т.М.Astahova Research Centre of Obstetrics, Gynecology & Perinatology, Moscow Mifepriston in emergency contraception

Main directions in the study of emergency contraception:  Creation of the International Consortium on Emergency Contraception  Enhancement of the WHO studies on that theme  Study of efficacy and comparison of different methods (Youzpe method, levonorgestrel and mifepriston in different doses)  Prolongation of an interval after an unprotected sex (from 72 tо 120 hrs)

Three regimens have been studied for emergency contraception Randomized double blind study in 15 family planning clinics in 10 countries 4136 healthy women with regular menstrual cycle).  Single dose of levonorgestrel – 1,5 мg  Two doses of levonorgestrel with an interval of 12 hrs  Single dose of Mifepriston – 10mg

Conclusion  «All three regimens are very efficient for emergency contraception and prevent a high per cent of pregnancies if taken during the first 5 days» Helene von Hertzen et al. Lancet 2002, 360:

Мifepriston Synthetic steroid, derivative of nortetisteron with antigestagen activity. Main indication is medical abortion Additional indications:  Treatment of uterine leyomyoma  Emergency contraception

Mifepriston (tablets 10 мg, Мir-Pharm)  As a means of emergency contraception mifepriston was registered after clinical trials and was approved for clinical practice in Russia in 2004

Objectives  To assess efficacy and safety of low-dose mifepristone(10мг) as a method of emergency contraception

Clinical Trials  Clinical trials on these indications were carried out for the first time at the Research center of Obstetrics, Gynecology & Perinatology of the Russian Academy of Medical Sciences, Russia  Coordinator of the trial - Member of the Academy of the Medical Sciences Vladimir I. Kulakov  A total of 30 women were included in this trial

Inclusion criteria:  Unprotected sex not more than 72 hrs tо visit  Reproductive age  Regular menstrual cycle during the last three months  No of psychic pathology  Patient informed consent

Exclusion criteria:  Using of other contraceptive methods  Postpartum period  Adrenal insufficiency  Thromboses in the medical/family history  Severe diabetes mellitus  Genital tumor

Indications for emergency contraception  Absence of any contraception in regular sexual life (25)  Failure of condom (2)  IUD expulsion during the cycle of the study (2)  Sexual abuse (1)  Age from 18 to 33 years, mean age 23,8+/- 1,7 years

Methods of study  Clinical (medical history, examinations etc.)  Questionnaire  Blood/urine tests, biochemical tests  Bacterioscopy of vaginal discharge  Tests for genital infections, HIV  Sonography of pelvis organs with Doppler modes  HCG test in blood  Progesterone test in blood

Study design included four visits:  Screening  7-8th days after the intended menstrual period  7-8 th days of the following menstrual period  Two months later the 3-rd visit

 No pregnancies А) verified by sonography В) verified by HCG Basic criteria - a number of pregnancies/ number of women using Mifepriston Parameters of efficiency

FINDINGS:

 No pregnancies in 30 patients

Results:  Side effects: long (in average up to 46 days) or postponed cycles days - in 5 (16%) patients on 2 – 3 visits  Cycle was regular in all patients - by the 4 visit  None of any other side effects

By the 4 th visit all 300 patients had regular cycles Namber of days

Remote results of examination (2-3 months after the 3 visit)  Regular menstrual cycle was in all patients  Mean duration of mensyrual cycle of 28,1+/-3,2 days  Mean duration of menstruation 5,4+/-0,7

Conclusion Results of the study testify of the following: Results of the study testify of the following:  High efficacy of Mifepriston in a single dose taken during 72 hrs as a method of emergency contraception  Its good tolerance  Normalizations of cycles in due time

Conclusion  «Mifepriston delayed ovulation that means prolonged cycle and delayed of following menstrual cycle»

Drawbacks: 1. Small number of cases 2. No of control group

Further investigations  Comparison of Mifepriston effect in the dose of 10 мg in different regimens of use: 72 and 120 hrs after unprotected sex Intended design: 150 patients in each group

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