A study was undertaken to determine whether ingestion of the selective
estrogen receptor modulator tamoxifen followed by vaginal administrat
ion of the prostaglandin misoprostol would be an effective medical met
hod of elective termination of early pregnancy. A clinical trial was c
onducted with a study group of 100 healthy women with pregnancies of 5
6 days gestational age or less who desired elective pregnancy terminat
ion. Each subject ingested 20 mg of tamoxifen once daily for 4 days fo
llowed 4 days later by intravaginal placement of four 200 mu g tablets
of misoprostol. If abortion did not occur within the next 24 h a seco
nd dose of 800 mu g of misoprostol was given. The main outcome measure
s were incidence of complete abortion, hemoglobin levels, duration of
vaginal bleeding, and incidence of side effects. Complete abortion occ
urred in 92 (92%, 95% CI 86.7 97.3%) of 100 subjects. Of these 92 wome
n, four aborted after ingesting tamoxifen without use of misoprostol,
84 within 24 h after receiving a single dose of misoprostol, one 21 da
ys following a single dose of misoprostol, and three after a second do
se of misoprostol was administered. There were six (6.0%) complete tre
atment failures and two (2%) incomplete abortions that required a dila
tation and curettage. The mean duration of uterine bleeding was 8.1 da
ys (range 1-34 days) and there was a median decrease in hemoglobin lev
el of 0.50 g/dL (+2.2 to -4.7 g/dL). Vomiting occurred in 28% of subje
cts and diarrhea in 8%. These initial data suggest that ingestion of t
amoxifen followed by intravaginal misoprostol may be an effective, eas
ily administered, and inexpensive method to electively induce complete
abortion in pregnancies of 56 days gestational age or less. Additiona
l studies are necessary to determine whether the addition of tamoxifen
increases the success rate compared with that obtained with the use o
f vaginally administered misoprostol by itself. (C) 1998 Elsevier Scie
nce Inc. All rights reserved.