Menstrual regulation with prostaglandin (Pg ONO 802) in Indonesia

This study was conducted to evaluate the safety, efficacy and acceptability of PGE1 vaginal suppositories (Pg ONO 802) in menstrual regulation. Each vaginal suppository contains 1 mg of 16,16 dimethyl-trans-delta 2 PGE1 methyl ester. Five suppositories were inserted as high as possible into the fornix posterior of the vagina at intervals of 3 h. Five hundred thirty four subjects with delay of menses mostly of up to 14 days were included in the study. Blood chemistry was evaluated and urine analysis performed in all subjects. Success of treatment was assessed on two alternative groups of criteria: (A) induction of bleeding by Pg ONO 802; (B) induction of bleeding achieved by Pg ONO 802 and not followed by surgical intervention. The success rate based on criteria A was 98.9%, and on criteria B 86%. If heavy bleeding occurred and signs of pregnancy were found during the trial period, intervention was made by vacuum aspiration or curettage when necessary. If bleeding did not occur and/or pregnancy continued, treatment was declared a failure and pregnancy was terminated by vacuum extraction or curettage. For non-pregnant subjects no intervention was made but careful re-evaluation was carried out. Mean duration of bleeding after Pg ONO 802 treatment was 6.7 days. Side-effects were generally mild. The incidence of diarrhea was 8.8%, nausea 7.8%, headache 5.8%, vomiting 2.8%; abdominal cramp occurred in as many as 66% of subjects. No treatment was given for these side-effects as they were within acceptable limits.(ABSTRACT TRUNCATED AT 250 WORDS)