BLEEDING PATTERNS IN POSTMENOPAUSAL WOMEN TAKING CONTINUOUS COMBINED OR SEQUENTIAL REGIMENS OF CONJUGATED ESTROGENS WITH MEDROXYPROGESTERONE ACETATE

Objective: To compare the bleeding patterns obtained with two continuo us combined and two sequential regimens of conjugated estrogens with m edroxyprogesterone acetate (MPA) and conjugated estrogens alone. Metho ds: This was a 1-year double-blind, randomized study done with 1724 po stmenopausal women at 99 sites in the United States and Europe. All fi ve treatment groups received 0.625 mg/day of conjugated estrogens. Gro ups A and B also took continuous daily doses of 2.5 and 5.0 mg of MPA, respectively. Groups C and D took 5.0 and 10.0 mg of MPA, respectivel y, for the last 14 days of each 28-day cycle. Group E took continuous daily doses of placebo to match MPA. Results: The two continuous combi ned regimens (A and B) produced amenorrhea in 61.4 and 72.8%, respecti vely, of all evaluable cycles. Generally, the incidence of amenorrhea increased and irregular bleeding decreased with longer duration of tre atment. In addition, amenorrhea occurred for at least the last seven c onsecutive cycles of the treatment year for about 40% of the patients taking the lower-dose continuous combined regimen (A), about 50% of th e patients taking the higher-dose continuous combined regimen (B), and about 50% of the patients taking conjugated estrogens alone. About 5% of the patients who took either of the sequential regimens (C or D) h ad amenorrhea during that time. Most of the cycles (81.3 and 77.0% in groups C and D, respectively) for patients taking the sequential conju gated estrogens-MPA regimens had regular withdrawal bleeding or withdr awal spotting. There was no bleeding or spotting in 75.5% of the cycle s for patients who took conjugated estrogens alone. Conclusions: Appro ximately half of the women who took the continuous combined conjugated estrogens-MPA regimens had amenorrhea, and the incidence tended to in crease during the study. Women who took the sequential regimens had go od cycle control with minimal irregular bleeding. More than half of th ose who took conjugated estrogens alone had amenorrhea.