Menstrual regulation by mifepristone plus prostaglandin: results from a multicentre trial. World Health Organization Task Force on Post-Ovulatory Methods of Fertility Regulation.
A multicentre trial was conducted to evaluate whether a combination regimen of a 600 mg dose of the antiprogestogen, 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 < or = 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.(ABSTRACT TRUNCATED AT 250 WORDS)
D000028:Abortion, Induced / Q000379:methods*; D000527:Alprostadil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D008599:Menstruation Disturbances / Q000188:drug therapy* / Q000503:physiopathology; D015735:Mifepristone / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011459:Prostaglandins E, Synthetic / Q000627:therapeutic use; D016896:Treatment Outcome; D014944:World Health Organization
D006454:Hemoglobins; D011459:Prostaglandins E, Synthetic; D015735:Mifepristone; C021182:gemeprost; D000527:Alprostadil