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

NCT ID: NCT01170195

Last Updated: 2010-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

Brief 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.

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.

Conditions

Postmenopausal Symptoms; Vaginal Dryness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Calmera-Licorice Root Extract (Licogen)

100 mg per day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Licogen

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

F&C Licorice Ltd

OTHER

Sponsor Role: lead

Responsible Party

F&C Licorice Ltd

Principal Investigators

Boris Kaplan, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Central Contacts

Boris Kaplan, MD

Role: CONTACT

bkaplan@clalit.org.il

972-3-9377534

Facility Contacts

Boris Kaplan, MD

Role: primary

bkaplan@clalit.org.il

972-3-9377534

Other Identifiers

5459

Identifier Type: -

Identifier Source: org_study_id