A multicentre clinical trial with RU 486 followed by 9-methylene-PGE2 vaginal gel for termination of early pregnancy: a dose-finding study. Indian Council of Medical Research Task Force on Hormonal Contraception.
A dose-finding study was carried out with two different doses of RU 486 (200mg or 600mg) each in combination with two doses of 9-methylene-PGE2 gel (3mg or 5mg) for termination of pregnancy between 7 to 28 days after missed menstrual period. It was observed that the success rates with 200mg RU 486 followed by 5mg 9-methylene-PGE2 gel were 94.5% and 89.6% in women with 7-14 days and 15-28 days of missed menstrual period, respectively. These rates were similar to those observed with 600mg RU 486 given along with 3mg or 5mg 9- methylene-PGE2 gel and were significantly higher than those observed with 200mg RU 486 given along with 3mg 9-methylene-PGE2 gel. All subjects except four started bleeding following the treatment. The average duration of bleeding in subjects with successful outcome (complete abortion) ranged between 7.0 to 11.8 days in the four different treatment schedules. There were no serious side effects with any of the treatment schedules; only one subject required transfusion of one unit of blood for heavy bleeding. The immediate and delayed complication rates were similar with the four treatment schedules.
D015064:16,16-Dimethylprostaglandin E2 / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000019:Abortifacient Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000028:Abortion, Induced; D000328:Adult; D005260:Female; D005782:Gels; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D014621:Vagina
D000019:Abortifacient Agents; D005782:Gels; C025505:meteneprost; D015735:Mifepristone; D015064:16,16-Dimethylprostaglandin E2