Human Reproduction, Vol. 10, No. 2, pp. 308-314, 1995
© 1995 European Society of Human Reproduction and Embryology
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Contraception: Menstrual regulation by mifepristone plus prostaglandin: results from a multicentre trial*
Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization 1211 Geneva 27, Switzerland
Correspondence: 1Correspondence should be addressed to: P.F.A.Van Look, Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, 1211 Geneva 27, Switzerland
A multicentre trial was conducted to evaluate whether a combination regimen of a 600 mg dose of the anti-progestogen, mifepristone, followed 48 h later by a 1 mg vaginal suppository of the prostaglandin analogue, gemeprost, could be an effective pharmacological method for menstrual regulation. A total of 228 women with menstrual delay of 
11 days were studied in nine centres; 35 of the women (15%) received the treatment without having been pregnant as determined by human chorionic gonadotrophin measurements performed retrospectively. The mifepristone—gemeprost regimen induced vaginal bleeding in all of the pregnant women and in all but two of the non-pregnant women, and a complete abortion in all but four of the 193 pregnant subjects. The four failures included one incomplete and two missed abortions and one continuing live pregnancy. Most women reported lower abdominal pain during the first few hours after gemeprost administration but few, if any, other side-effects were observed. Most non-pregnant women described the induced vaginal bleeding to be comparable with — albeit somewhat longer than — a normal menstruation. In pregnant women the duration of the bleeding was on average longer, and the amount greater, than normal menstruation, but haemoglobin concentrations in these women as well as in the non-pregnant subjects were not affected. The overall success rate (97.4%; 95% confidence interval: 94.4–99.0%) of the regimen employed in this pilot trial strongly suggests that the combination of an antiprogestogen followed by a suitable prostaglandin is potentially useful for menstrual regulation and probably also as a late luteal, once-a-month contraceptive. Further research is needed to optimize this regimen and assess its practical value and acceptability.
Key words: gemeprost/menses induction/menstrual regulation/mifepristone/prostaglandin
*Study coordinators were P.F.A.Van Look, E.M.Belsey, N.BernersLee and N.Laperriere, and the manuscript was prepared by P.F.A.Van Look, H.von Hertzen, D.Machin and M.Ali, Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland
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