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

Gynecol Endocrinol. 2015 May;31(5):384-7. doi: 10.3109/09513590.2014.1003294. Epub 2015 Feb 23.

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).

Keywords: Body composition; HRT; NETA; climacteric symptoms; drospirenone; insulin resistance; menopause; metabolism.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adipose Tissue
  • Androstenes / therapeutic use*
  • Body Composition
  • Body Water
  • Body Weight
  • Double-Blind Method
  • Drug Therapy, Combination
  • Estradiol / therapeutic use*
  • Estrogen Replacement Therapy*
  • Estrogens / therapeutic use*
  • Female
  • Hot Flashes / drug therapy*
  • Humans
  • Insulin Resistance
  • Middle Aged
  • Mineralocorticoid Receptor Antagonists / therapeutic use
  • Norethindrone / therapeutic use*
  • Postmenopause
  • Progesterone Congeners / therapeutic use*
  • Quality of Life
  • Treatment Outcome

Substances

  • Androstenes
  • Estrogens
  • Mineralocorticoid Receptor Antagonists
  • Progesterone Congeners
  • Estradiol
  • drospirenone
  • Norethindrone