THE EFFECT OF 20 MU-G ETHINYL ESTRADIOL 1 MG NORETHINDRONE ACETATE (MINESTRIN(TM)), A LOW-DOSE ORAL-CONTRACEPTIVE, ON VAGINAL BLEEDING PATTERNS, HOT FLASHES, AND QUALITY-OF-LIFE IN SYMPTOMATIC PERIMENOPAUSAL WOMEN

One hundred and thirty two perimenopausal women with climacteric sympt oms participated in a placebo-controlled, double-blind, randomized, pa rallel group study of the oral contraceptive Minestrin(TM) containing 20 mu g ethinyl estradiol/l mg norethindrone acetate (EE 20 mu g/NA 1 mg). Bleeding patterns, hot flashes, quality of life, and safety were assessed over a 24-week (6 cycle) interval. There was no difference in the average duration of bleeding episodes between the treatment group s, but EE 20 mu g/NA 1 mg therapy shortened menstrual cycle duration d r, < 0.05), decreased its variability, and markedly lowered bleeding s everity (p < 0.01). The incidence and duration of clots/flooding were reduced in the EE 20 mu g/NA 1 mg group for the last 3 cycles (p < 0.0 5). The frequency of intermenstrual bleeding was higher in the oral co ntraceptive users during the first 12 weeks (p < 0.05), but no differe nce was observed between the two groups after 3 months of treatment. T he frequency and severity of hot flashes were decreased in the treated group, but statistical significance was not reached due to large vari ability. Quality of life assessments indicated significant improvement s in the oral contraceptive treatment group. Adverse events were simil ar in occurrence and type in treated and control groups; however, norm alization of hematologic parameters and beneficial effects on endometr ium were noted more often in the active treatment group. Compared with placebo, EE 20 mu g/NA 1 mg improved cycle control, decreased bleedin g severity, and improved quality of life while offering a similar safe ty profile.