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

Abstract

Objective: To compare compliance, symptom control, bleeding patterns, endometrial response, and lipid changes in postmenopausal women treated with transdermal E2 and a regimen of either intermittent or continuous dosing of progestin.

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 been amenorrheic for at least 1 year. Fifty women were randomly assigned to receive each regimen.

Intervention(s): All patients received 50-microg E2 patches and medroxyprogesterone acetate, either 5 mg twice per week or 2.5 mg daily. The bleeding pattern was registered in diary cards. Endometrial status was assessed by vaginal ultrasound and endometrial biopsy. Lipid levels were measured by ELISA.

Main outcome measure(s): The number of patients who dropped out of the study and the number of days each patient reported spotting or bleeding were recorded. Endometrial thickness was measured and histologic examination of the endometrial tissue was performed. Plasma levels of total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein 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 bleeding 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 atrophic endometria suggests the possibility of further reduction of the progestin dose.