NCT00522873

Endometrial Safety Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Postmenopause

Interventions

Type	Name	Description
DRUG	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
DRUG	0.5mg NETA / 1.0mg E2 (Activella)	One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-08-30
• Last updated: 2014-12-31
• Results posted: 2012-06-28

Locations

59 sites across 8 countries: United States, Argentina, Austria, Brazil, Denmark, Italy, Mexico, Russia