Two-year prospective, randomized trial comparing an innovative twice-a-week progestin regimen with a continuous combined regimen as postmenopausal hormone therapy

Objective: To compare compliance, symptom control, bleeding patterns, endom etrial response, and lipid changes in postmenopausal women treated with tra nsdermal E-2 and a regimen of either intermittent or continuous dosing of p rogestin. Design: Randomized, prospective study. Setting: Menopausal Outpatient Clinic at an academic tertiary care hospital . Patient(s): One hundred women who had reached menopause naturally and had b een amenorrheic for at least 1 year. Fifty women were randomly assigned to receive each regimen. Intervention(s): All patients received 50-mu g E-2 patches and medroxyproge sterone acetate, either 5 mg twice per week or 2.5 mg daily. The bleeding p attern was registered in diary cards. Endometrial status was assessed by va ginal ultrasound and endometrial biopsy. Lipid levels were measured by ELIS A. Main Outcome Measure(s): The number of patients who dropped out of the stud y and the number of days each patient reported spotting or bleeding were re corded. Endometrial thickness was measured and histologic examination of th e endometrial tissue was performed. Plasma levels of total cholesterol, tri glycerides, high-density lipoprotein cholesterol, and low-density lipoprote in cholesterol were measured. Result(s): Fourteen women dropped out of the intermittent dosing group and 13 dropped out of the continuous dosing group. Irregular spotting or bleedi ng occurred at a similar rate in both groups. Biopsies performed at the end of the study showed adequate endometrial stabilization in both groups. No significant changes in lipid levels were detected with either regimen. Conclusion(s): Both regimens were similarly effective. The high rate of atr ophic endometria suggests the possibility of further reduction of the proge stin dose. (C) 1998 by American Society for Reproductive Medicine.