Endometrial Safety Study

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

Outcome

Met primary endpoint

paper No evaluable women in the DRSP/E2 or NETA/E2 groups had an endometrial biopsy result of 'hyperplasia or worse'. PMID 23531117 ↗

paper The low-dose, 0.25 mg DRSP/0.5 mg E2 dose combination met the criteria for endometrial safety PMID 23531117 ↗

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.