CLINICAL-EVALUATION OF NEAR-CONTINUOUS ORAL MICRONIZED PROGESTERONE THERAPY IN ESTROGENIZED POSTMENOPAUSAL WOMEN

In an open non-comparative prospective trial of 12 months' duration, w e investigated the role of a novel hormone replacement therapy regimen in 40 postmenopausal women who sought hormone replacement therapy. Th e regimen consisted of continuous administration of 0.625 mg of conjug ated equine estrogen coupled with a fixed low-nose of micronized oral progesterone administered for 23 days every calendar month. The regime n was well tolerated, producing MO major side-effects and was effectiv e in relieving menopausal symptoms. The study showed that 40% of the w omen experienced side-effects and 20% withdrew from the study. Half of the 20% of the women who dropped out did so for reasons not related t o treatment. All symptomatic women experienced improvement after the 1 st month, and virtually all were asymptomatic by the 3rd month of trea tment, persisting until the end of the trial with the average number o f hot flushes per day declining from the pretreatment levels by 96%. A menorrhea war observed in 47% of patients, amenorrhea and minimal vagi nal bleeding in 78% but acyclic bleeding was present in 28% of those i n whom bleeding war re-established. Endometrial atrophy was induced in tile majority of patients and no atypical endometrial hyperplasia was encountered. No significant char?ges were observed in blood glucose o r liver enzymes. The mean percentage changes from baseline for serum c holesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoproteins (LDL) and LDL/HDL ratio were -6%, +32% (p < 0.001), -16% (p < 0.05), +15% (p < 0.05) and -23% (p < 0.05), respecti vely. The regimen was clinically effective and its apparent lark of ma jor side-effects, the protective effect on the endometrium, the added advantage of minimal vaginal bleeding and the beneficial effect on lip id/lipoprotein levels, offer an attractive therapy and improved compli ance with postmenopausal hormone replacement therapy.