Clinical effect of hormonal replacement therapy with estradiol associated with noretisterone or drospirenone. A prospective randomized placebo controlled study

Abstract

The study was performed to compare the clinical effect of a hormone replacement therapy (HRT) with two different progestins. Postmenopausal women (PMW) with climacteric symptoms (CS) randomly received for 12 months orally, either placebo (n = 20), 1 mg estradiol (E) plus 0.5 mg noretisterone acetate (NETA; n = 40), or 2 mg drospirenone (DRSP; n = 40), a testosterone- and spironolactone-derived molecule, respectively. Weight (W) declined only during E/DRSP (p < 0.04 versus placebo). Fat mass (FM) decreased, similarly, during E/NETA and E/DRSP. Intracellular water (ICW) did not change, while extracellular water (ECW) decreased during E/DRSP (p < 0.0001) (p < 0.002 versus E/NETA). During E/NETA and E/DRSP, similar decreases were observed for insulin resistance (IR) by the homeostatic model assessment for IR (HOMA-IR) (p < 0.0001 versus placebo for both), systolic (p < 0.04 versus placebo for both) and diastolic (p < 0.002) blood pressure (BP). Lipids did not change. In comparison to placebo CS, by the Kupperman Index (KI), significantly declined (p < 0.0001) during E/NETA or E/DRSP. Menopause-specific Quality of Life (MENQoL) significantly declined versus placebo (p < 0.04) during both E/NETA and E/DRSP. In conclusion, differences between the two progestins are mainly limited to body composition (BC), where the addition of DRSP decreases ECW and body W (BW).

• Body composition
• climacteric symptoms
• drospirenone
• HRT
• insulin resistance
• menopause
• metabolism
• NETA

Acknowledgements

We thank Roberto Orlandi, PhD, and Prof. Domenico de Aloysio for their kind and critical support in designing and promoting the study.

Declaration of interest

The study was partially supported by an unrestricted grant from Bayer-Schering. The authors Angelo Cagnacci and Costantino Di Carlo declare having delivered lectures or having participated to advisory boards organized by Bayer-Schering and Novo-Nordisk. The authors Anna Maria Paoletti and Gian Benedetto Melis declare having delivered lectures or having participated to advisory boards organized by Bayer-Schering.