The Effect of 20 ??g Ethinyl Estradiol/1 mg Norethindrone Acetate (MinestrinTM), a Low-Dose Oral Contraceptive, on Vaginal Bleeding Patterns, Hot Flashes, and Quality of Life in Symptomatic Perimenopausal Women

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Abstract
One hundred and thirty two perimenopausal women with climacteric symptoms participated in a placebo-controlled, double-blind, randomized, parallel group study of the oral contraceptive Minestrin™ containing 20 μg ethinyl estradiol/1 mg norethindrone acetate (EE 20 μg/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 groups, but EE 20 μg/NA 1 mg therapy shortened menstrual cycle duration (p < 0.05), decreased its variability, and markedly lowered bleeding severity (p < 0.01). The incidence and duration of clots/flooding were reduced in the EE 20 μg/NA 1 mg group for the last 3 cycles (p < 0.05). The frequency of inter-menstrual bleeding was higher in the oral contraceptive users during the first 12 weeks (p < 0.05), but no difference was observed between the two groups after 3 months of treatment. The frequency and severity of hot flashes were decreased in the treated group, but statistical significance was not reached due to large variability. Quality of life assessments indicated significant improvements in the oral contraceptive treatment group. Adverse events were similar in occurrence and type in treated and control groups; however, normalization of hematologic parameters and beneficial effects on endometrium were noted more often in the active treatment group. Compared with placebo, EE 20 μg/NA 1 mg improved cycle control, decreased bleeding severity, and improved quality of life while offering a similar safety profile.

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