Once-a-month treatment with a combination of mifepristone and the prostaglandin analogue misoprostol

A 2-center study was undertaken to examine the efficacy safety and acceptability of a once-a-month administration of a combination of 200 mg mifepristone and 0.4 mg misoprostol for menstrual regulation in the late luteal phase. About 24 women from Shanghai and 8 from Stockholm were administered 200 mg mifepristone taken orally before or on the day of menstruation followed by 0.4 mg misoprostol taken orally after 48 hours. Urine samples were collected during 3 days before to 4 days after ovulation for an analysis of luteinizing hormone. In addition a plasma beta human chorionic gonadotrophin was measured immediately before intake of mifepristone. Volunteers were to participate for 6 months but the study was disrupted prematurely due to low efficacy. In 125 treatment cycles the total pregnancy rate was 17.6% (22 pregnancies) and the failure pregnancy rate was 4.0%. Discontinuation of the study among 8 women was due to bleeding disturbances seen in 15 cycles (12%). In conclusion late luteal phase treatment with a combination of mifepristone and misoprostol was not effective enough to be used for menstrual regulation.