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Endometrial Safety Study

Postmenopause Clinical Trial

Official title:
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 (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women

Clinical Trial Summary

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00522873
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 3
Start date August 2007
Completion date August 2009
View Details
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