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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01170195
• Other study ID #: 5459
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 26, 2010
• Last updated: July 26, 2010
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2010
• Source: F&C Licorice Ltd
• Contact: Boris Kaplan, MD
• Phone: 972-3-9377534
• Email: bkaplan[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Postmenopausal Symptoms
• Vaginal Dryness

Intervention

Dietary Supplement:
• Calmera-Licorice Root Extract (Licogen)
100 mg per day

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
F&C Licorice Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No