Clinical Experiences with a Combination of Estradiol Valerate and Cyproterone Acetate for Hormone Replacement

Abstract

Estrogen replacement in pre- and postmenopausal women provides an effective relief of typical climacteric complaints. However, the addition of a progestogen is essential to reduce the risk of endometrial cancer and to control cycle irregularities in the perimenopausal period. In postmenopausal women the androgen formation is almost unchanged and responsible for lowering HDL concentrations on the one hand and is involved in the development of insulin resistance on the other. Thus, it is expected that the combination of estradiol valerate (E2V) with cyproterone acetate (CPA), a progestogen with strong antiandrogenic effects, will augment the beneficial effects of estradiol on lipid and carbohydrate metabolism. For this reason climen was developed and is now available in 41 countries all over the world. It is a preparation with 21 days of 2 mg E2V and a 10-day addition of 1 mg CPA. This regimen is followed by a treatment-free 7-day interval. In a randomized, double-blind, multicenter study, 594 patients were treated for 12 months: 293 patients with climen and the remaining 301 patients, as control, were given a combination of 2 mg estradiol valerate for 21 days plus 0.5 mg norgestrel for 10 days.