ABSTRACT
OBJECTIVE: To compare the effects of continuous combined 17beta-estradiol (E2) plus norethisterone (acetate) [NET(A)] therapy by either intranasal or oral administration on the lipid profile in postmenopausal women. DESIGN: Randomized, double-blind, multicenter trial. SETTING: Gynecologic outpatient department. PATIENT(S): Two-hundred thirty-three healthy postmenopausal women. INTERVENTION(S): Women received continuous combined hormone therapy, either intranasal E2/NET (175 microg/275 microg) as a spray (n = 117) or oral E2/NETA (1 mg/0.5 mg) as a capsule (n = 116), for 1 year. MAIN OUTCOME MEASURE(S): Fasting plasma concentrations of lipids and (apo)lipoproteins; and atherogenic indices at baseline and after 12, 24, and 52 weeks of treatment. RESULT(S): We found a significant (P < .001) decrease from baseline in both treatment groups in total, low-density lipoprotein- (LDL), high-density lipoprotein- (HDL), and HDL2-cholesterol, in triglycerides, apolipoprotein B (apoB), and lipoprotein(a). Levels of HDL3-cholesterol and apolipoprotein A1 (apoA1) were transiently decreased in the intranasal group. In the oral group, compared with the intranasal group, the decrease was larger for ratio total and LDL-cholesterol and lipoprotein(a) and smaller for triglycerides and apoA1. In the oral group, the ratios total/HDL cholesterol and LDL/HDL cholesterol were lowered, and the ratio apoB/LDL was increased, more than in the intranasal group. CONCLUSION(S): Both intranasal and oral E2/NET(A) therapy improved the lipid profile of healthy postmenopausal women, with some effects being more pronounced after oral administration.