Spotlight on Estradiol and Norgestimate as Hormone Replacement Therapy in Postmenopausal Women

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ADIS SPOTLIGHT

© Adis International Limited. All rights reserved.

Spotlight on Estradiol and Norgestimate as Hormone Replacement Therapy in Postmenopausal Women1 Monique P. Curran and Antona J. Wagstaff Adis International Limited, Langhorne, Pennsylvania, USA

Contents Abstract . . . . . . . . . . 1. Pharmacodynamic Profile . 2. Pharmacokinetic Properties 3. Therapeutic Use . . . . . . . 4. Tolerability . . . . . . . . . . 5. Dosage and Administration

Abstract

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The focus of this review is hormone replacement therapy (HRT) with continuous administration of micronized, oral 17β-estradiol 1 mg/day (herein referred to as continuous estradiol) plus micronized, oral norgestimate 90 μg/day administered for 3 days then withdrawn for 3 days in a 6-day repeating sequence (herein referred to as intermittent norgestimate). According to data from randomized, comparative trials of 1 year’s duration, continuous estradiol 1 mg/day plus intermittent norgestimate 90 μg/day relieves climacteric symptoms (vasomotor symptoms and vulvovaginal atrophy) in postmenopausal women. Continuous estradiol 1 mg/day plus intermittent norgestimate 90 μg/day appeared as effective as estradiol 1 mg/day alone or continuous estradiol 2 mg/day plus continuous norethisterone acetate 1 mg/day in the treatment of postmenopausal women with vasomotor symptoms. Continuous estradiol 1 mg/day plus intermittent norgestimate 90 μg/day was as effective as continuous estradiol 1 mg/day in causing the maturation of vaginal epithelial cells. In a randomized, double-blind study, bone mineral density (BMD) increased to a significantly greater extent and the rate of bone turnover was slower in postmenopausal women treated with continuous oral estradiol 1 mg/day plus intermittent norgestimate 90 μg/day than in placebo-treated patients. Two randomized, double-blind studies indicated that the addition of norgestimate 90 μg/day to continuous estradiol 1 mg/day did not attenuate the beneficial effects of estradiol on lipid parameters. Continuous estradiol 1 mg/day plus intermittent norgestimate 90 μg/day was associated with increases in mean serum high density lipoprotein (HDL)-cholesterol levels and decreases in total cholesterol, low density lipoprotein (LDL)-cholesterol and lipoprotein (a) levels, compared with baseli