Bleeding profile and endometrial safety of continuous combined regimens 1 mg 17beta-estradiol/trimegestone versus 1 or 2 mg 17beta-estradiol/norethisterone acetate in postmenopausal women

Abstract

Objective. To compare the bleeding profile and endometrial safety of continuous combined 1 mg 17β-estradiol (17β-E₂) and 0.125 mg trimegestone (TMG) with those of two continuous combined 17β-E₂ and norethisterone acetate (NETA) regimens.

Study design. This was a double-blind, randomized, multicenter study conducted in 12 European countries and Israel over a 2-year period. Healthy postmenopausal women with an intact uterus were given either 1 mg 17β-E₂/0.125 mg TMG, 2 mg 17β-E₂/1 mg NETA or 1 mg 17β-E₂/0.5 mg NETA for up to 26 cycles, each of 28 days.

Results. The percentage of amenorrheic women was greater in most cycles up to cycle 13 in the 1 mg 17β-E₂/0.125 mg TMG group than in the comparator groups. The mean number of bleeding days was similar in the 1 mg 17β-E₂/0.125 mg TMG and the 1 mg 17β-E₂/0.5 mg NETA groups, but greater in the 2 mg 17β-E₂/1 mg NETA group. No endometrial hyperplasia was observed for any group.

Conclusion. Continuous combined 1 mg 17β-E₂/0.125 mg TMG exhibits a more favorable bleeding profile than 1 mg 17β-E₂/0.5 mg NETA up to 1 year, while providing an adequate protective effect on the endometrium.

Keywords:

• Trimegestone
• estradiol
• norethisterone acetate
• continuous combined hormone replacement therapy
• menopause
• bleeding profile
• endometrial safety
• amenorrhea