Fertility and sterility · 2006
Toward developing a once-a-month pill: a double-blind, randomized, controlled trial of the effect of three single doses of mifepristone given at midcycle on the pattern of menstrual bleeding.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Narvekar Nitish, Glasier Anna, Dada Kai, Van der Spuy Zephne, Ho Pak C, Cheng Linan, Baird David T
Аннотация
OBJECTIVE: To test the feasibility of timing the administration of mifepristone as a once-a-month contraceptive pill on the 12th day before the next menses, as calculated from the length of the previous menstrual cycles.
DESIGN: Double-blind, randomized, controlled trial.
SETTING: Five family planning centers across the world.
PATIENT(S): Three hundred ninety-nine women attending family planning clinics.
INTERVENTION(S): Randomized to receive 10, 25, or 200 mg of mifepristone or a placebo.
MAIN OUTCOME MEASURE(S): Lengthening or shortening of the normal menstrual cycle length following administration of the drug by at least 5 days.
RESULT(S): The menstrual period came within 5 days of the predicted date in 88% of women receiving the placebo, 84% of women receiving 10 mg, 72% of women receiving 25 mg of mifepristone, and only 48% of women treated with 200 mg of mifepristone. Increasing the dose of mifepristone was associated with an increased chance of having a delayed period (P<.001). Only 45% of women were in the peri-ovulatory phase of the cycle according to LH and P measurements on the day of drug administration. Women treated before ovulation were more likely to have delayed menses with all three doses of mifepristone.
CONCLUSION(S): Because of the disruption in cycle length, it appears unlikely that mifepristone administered once a month, at a calendar-based time, would provide a reliable method of contraception.
DESIGN: Double-blind, randomized, controlled trial.
SETTING: Five family planning centers across the world.
PATIENT(S): Three hundred ninety-nine women attending family planning clinics.
INTERVENTION(S): Randomized to receive 10, 25, or 200 mg of mifepristone or a placebo.
MAIN OUTCOME MEASURE(S): Lengthening or shortening of the normal menstrual cycle length following administration of the drug by at least 5 days.
RESULT(S): The menstrual period came within 5 days of the predicted date in 88% of women receiving the placebo, 84% of women receiving 10 mg, 72% of women receiving 25 mg of mifepristone, and only 48% of women treated with 200 mg of mifepristone. Increasing the dose of mifepristone was associated with an increased chance of having a delayed period (P<.001). Only 45% of women were in the peri-ovulatory phase of the cycle according to LH and P measurements on the day of drug administration. Women treated before ovulation were more likely to have delayed menses with all three doses of mifepristone.
CONCLUSION(S): Because of the disruption in cycle length, it appears unlikely that mifepristone administered once a month, at a calendar-based time, would provide a reliable method of contraception.