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A randomized, placebo-controlled, double-blind, multi-national study to demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone in the treatment of vasomotor symptoms in postmenopausal women in comparison to placebo over 3 months, and to investigate the bleeding pattern over a double-blind treatment period of one year compared with continuous combined 1 mg estradiol and 5 mg. dydrogesterone.

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Trial Profile

A randomized, placebo-controlled, double-blind, multi-national study to demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone in the treatment of vasomotor symptoms in postmenopausal women in comparison to placebo over 3 months, and to investigate the bleeding pattern over a double-blind treatment period of one year compared with continuous combined 1 mg estradiol and 5 mg. dydrogesterone.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2021

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At a glance

  • Drugs Estradiol/dydrogesterone (Primary)
  • Indications Hot flashes; Menopausal syndrome; Vasomotor symptoms
  • Focus Therapeutic Use

Most Recent Events

  • 03 Aug 2010 Results published in Maturitas.
  • 03 Aug 2010 Primary endpoint 'Climacteric symptoms' has been met.
  • 12 Mar 2008 Biomarkers information updated

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