Clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women - Scientific guideline

This document provides recommendations for the development of medicinal products intended for the treatment of oestrogen deficiency symptoms in post-menopausal woman. It applies to products containing as an active substance an oestrogen alone, an oestrogen in combination with a progestogen or a progestogen to be given with an oestrogen.

Keywords: Hormone replacement therapy (HRT)

Current effective version

Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women - Revision 1

Adopted Reference Number: EMEA/CHMP/021/97 Rev. 1 Legal effective date: 01/05/2006