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

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Dryness; Postmenopausal Symptoms
• Intervention / Treatment: Dietary supplement: Calmera-Licorice Root Extract (Licogen)

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women between the ages 45-60,
2. Who are post-menopausal (proved by a laboratory test of FSH > 30 International units),
3. Patients who report having post-menopausal symptoms, who report having, at least 5-7 hot flushes per day, as well as wakeful night episodes and nocturnal sweating (measured by Greenscale or Cooperman Index).

Exclusion Criteria:

1. Female patients who are outside the age boundaries of 45-60,
2. Have FSH <30
3. Patients who presently have cancer of any kind,
4. Patients that are on any other treatment for relieving post-menopausal symptoms
5. Patients who have contraindication to Licorice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A beneficial effect of the licorice extract on postmenopausal symptoms (vasomotor symptoms, and nocturnal episodes) in symptomatic postmenopausal women	This outcome will be measured by: a diary in which she should report daily. The reporting would be for 3 parameters: number of hot flushes per day, wakefull night episodes and nocturnal sweating measured by Greens Climateric Scale	20 weeks
A beneficial effect of the licorice extract on vaginal complaints in symptomatic postmenopausal women	this objective will be measured by Pap Smear, Vaginal Ultra sound and vaginal PH	20 weeks

Collaborators and Investigators

• Sponsor: F&C Licorice Ltd
• Investigators: Principal Investigator: Boris Kaplan, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ANTICIPATED): September 1, 2011
• Study Completion (ANTICIPATED): September 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (ESTIMATE): July 27, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2010
• Last Update Submitted That Met QC Criteria: July 26, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Postmenopausal; licorice; vaginal complaints
• Other Study ID Numbers: 5459