Prolonged effects of a novel, low-dosage continuous progestin-cyclic estrogen replacement program in postmenopausal women.
OBJECTIVE: Our objective was to ascertain long-term tolerability and effects of a novel, low-dosage continuous progestin-cyclic estrogen regimen on vasomotor flushing, vaginal bleeding patterns, bone density, and plasma lipoprotein lipids. STUDY DESIGN: Eighteen postmenopausal women with climacteric symptoms received low doses of dl-norgestrel (0.075 mg/day) continuously and 17 beta-estradiol (1 mg/day) intermittently (25 of 28 days) for 3 years. The results were compared with baseline values. RESULTS: The hormonal regimen was well tolerated. Vaginal bleeding, vaginal spotting, and vasomotor flushing occurred in only 0.4%, 4.2%, and 7.7% of cycles, respectively. Bone density was stable. Mean fasting plasma total cholesterol concentration fell 19%, low-density lipoprotein cholesterol 23%, high-density lipoprotein cholesterol 13%, and triglycerides 31% (p less than 0.01) over the 3-year period, while the ratios of low-density lipoprotein cholesterol/high-density lipoprotein cholesterol and total cholesterol/high-density lipoprotein cholesterol decreased by 14% and 10%, respectively. CONCLUSION: Long-term compliance with female hormonal replacement is feasible once vaginal bleeding is essentially eliminated, allowing for potentially better prophylaxis against coronary heart disease, osteoporosis, endometrial cancer, and stroke.