BACKGROUND: Mifepristone in a dose of 10 mg is an effective emergency contraceptive when administered up to 120 hours after unprotected coitus. METHODS: Between May 2003 and February 2005, we conducted in Cuba a single-arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception up to 6 days after unprotected coitus. A total of 635 women who requested emergency contraception after a single act of unprotected intercourse were included in the study. RESULTS: After treatment there were 7/635 (1.1%) pregnancies (95% CI 0.4-2.3%). Pregnancy that might have occurred was prevented in 88.0% of the cases (95% CI 77.1-95.1%). The most common side effects reported by participants were fatigue (10.7%), dizziness (6.1%) and nausea (4.9%); vomiting was only reported by 0.6%. In 38/635 (6.0%) women menstruation was delayed more than 7 days. CONCLUSIONS: Mifepristone 10 mg administered is an effective emergency contraceptive with an acceptable profile of side effects up to five days, but greater studies are necessary to verify its efficacy up to 6 days after unprotected intercourse.
BACKGROUND:Mifepristone in a dose of 10 mg is an effective emergency contraceptive when administered up to 120 hours after unprotected coitus. METHODS: Between May 2003 and February 2005, we conducted in Cuba a single-arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception up to 6 days after unprotected coitus. A total of 635 women who requested emergency contraception after a single act of unprotected intercourse were included in the study. RESULTS: After treatment there were 7/635 (1.1%) pregnancies (95% CI 0.4-2.3%). Pregnancy that might have occurred was prevented in 88.0% of the cases (95% CI 77.1-95.1%). The most common side effects reported by participants were fatigue (10.7%), dizziness (6.1%) and nausea (4.9%); vomiting was only reported by 0.6%. In 38/635 (6.0%) women menstruation was delayed more than 7 days. CONCLUSIONS:Mifepristone 10 mg administered is an effective emergency contraceptive with an acceptable profile of side effects up to five days, but greater studies are necessary to verify its efficacy up to 6 days after unprotected intercourse.