Norplant(R), a systemic contraceptive, has been used extensively thoug
hout the world. A major problem for consumers utilizing Norplant has b
een irregular, unpredictable uterine bleeding or spotting, This study
seeks to determine whether or not an appropriate treatment could be fo
und that will reduce the incidence of spotting and bleeding, Both a pi
lot study and an interim report of a multi-center trial utilizing ethi
nyl estradiol 20 mu g for 10 days, versus Ibuprofen 800 mg three times
a day for 5 days, versus placebo is reported. Based on the interim an
alysis of the multi-center trial, there is a reduction in the mean num
ber of spotting days with one of the three treatments compared to the
other two treatments (p = 0.044), There was no difference in the numbe
r of bleeding days between treatment regimen, It appears from a review
of the literature that both oestrogen, progesterone, and non-sterioda
l anti-inflammatory agents may. reduce the number of bleeding days or
inhibit acutely the bleeding in women utilizing Norplant. The completi
on of this randomized multi-center trial will hopefully give us furthe
r insight into an effective treatment for controlling the irregular bl
eeding and/or spotting that occurs in Norplant users.