A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (17b estradiol [E2]/drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with E2/DRSP with the bleeding pattern of subjects treated with E2/norethisterone acetate when used for hormone therapy for 1 year in post-menopausal women.

Trial Profile

A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (17b estradiol [E2]/drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with E2/DRSP with the bleeding pattern of subjects treated with E2/norethisterone acetate when used for hormone therapy for 1 year in post-menopausal women.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2014

At a glance

  • Drugs Estradiol/drospirenone (Primary) ; Estradiol/norethisterone
  • Indications Menopausal syndrome
  • Focus Adverse reactions
  • Sponsors Bayer
  • Most Recent Events

    • 05 Aug 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 12 Jan 2009 Planned end date changed from 1 Aug 2009 to 1 Jul 2009 as reported by ClinicalTrials.gov.
    • 12 Jan 2009 Planned number of patients changed from 600 to 662 as reported by ClinicalTrials.gov.
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