Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms

Postmenopausal Symptoms Clinical Trial

Official title: Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms

Status Not yet recruiting

Clinical Trial Summary

The purpose of the proposed study is to test the effect of Licorice Root Extract- Licogen on postmenopausal symptoms in postmenopausal women. Specifically, the study will also test the effect of the licorice extract on vaginal dryness.

Clinical Trial Description

The estrogenic properties of glabridin, the major isoflavan in licorice root, were tested in view of the resemblance of its structure and lipophilicity to those of estradiol. The results indicate that glabridin is a phytoestrogen, binding to the human estrogen receptor and stimulating creatine kinase activity in rat uterus, epiphyseal cartilage, diaphyseal bone, aorta, and left ventricle of the heart. The stimulatory effects of 2.5-25 mg/animal glabridin were similar to those of 5 mg/animal estradiol. Chemical modification of glabridin showed that the position of the hydroxyl groups has a significant role in binding to the human estrogen receptor and in proliferation-inducing activity. Glabridin was found to be three to four times more active than 2*-O-methylglabridin and 4*-O-methylglabridin, and both derivatives were more active than 2*,4*- O-methylglabridin. The effect of increasing concentrations of glabridin on the growth of breast tumor cells was biphasic. Glabridin showed an estrogen receptor-dependent, growth-promoting effect at low concentrations (10 nM-10 mM) and estrogen receptor-independent antiproliferative activity at concentrations of >15 mM. This is the first study to indicate that isoflavans have estrogen-like activities. Glabridin and its derivatives exhibited varying degrees of estrogen receptor agonism in different tests and demonstrated growth-inhibitory actions on breast cancer cells. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopausal Symptoms
• Vaginal Dryness

• NCT number: NCT01170195
• Study type: Interventional
• Source: F&C Licorice Ltd
• Contact: Boris Kaplan, MD
• Phone: 972-3-9377534
• Email: bkaplan@clalit.org.il
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2010
• Completion date: September 2011