drugset

drugset / Trial / NCT00522873

Endometrial Safety Study

NCT00522873 ↗

Phase 3 Completed 662 enrolled Bayer Diagnostic Cytology Laboratory · collab Laboratorium für Klinische Forschung · collab University of California, San Francisco · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2007-08
Primary completion: 2009-08
Completion: 2009-08

Publications

Results Genazzani AR, Schmelter T, Schaefers M, Gerlinger C, Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17beta-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/13697137.2013.783797. Epub 2013 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	0.5 mg	Oral
Subject	Estradiol	Other / unclassified	1 mg	Oral
Comparator	Norethindrone	Unknown	0.5 mg	Oral
Subject	drospirenone	Unknown	0.25 mg	Oral

Indications

No indication recorded.