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.
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
- 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.