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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by F&C Licorice Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
F&C Licorice Ltd
ClinicalTrials.gov Identifier:
NCT01170195
First received: July 26, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postmenopausal Symptoms
Vaginal Dryness
Dietary Supplement: Calmera-Licorice Root Extract (Licogen)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms

Resource links provided by NLM:


Further study details as provided by F&C Licorice Ltd:

Primary Outcome Measures:
  • A beneficial effect of the licorice extract on postmenopausal symptoms (vasomotor symptoms, and nocturnal episodes) in symptomatic postmenopausal women [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

    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


  • A beneficial effect of the licorice extract on vaginal complaints in symptomatic postmenopausal women [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    this objective will be measured by Pap Smear, Vaginal Ultra sound and vaginal PH


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Calmera-Licorice Root Extract (Licogen)
    100 mg per day
    Other Name: 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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170195

Contacts
Contact: Boris Kaplan, MD 972-3-9377534 bkaplan@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel
Contact: Boris Kaplan, MD    972-3-9377534    bkaplan@clalit.org.il   
Principal Investigator: Boris Kaplan, MD         
Sponsors and Collaborators
F&C Licorice Ltd
Investigators
Principal Investigator: Boris Kaplan, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Nir Kedem, F&C Licorice Ltd
ClinicalTrials.gov Identifier: NCT01170195     History of Changes
Other Study ID Numbers: 5459
Study First Received: July 26, 2010
Last Updated: July 26, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by F&C Licorice Ltd:
Postmenopausal
licorice
vaginal complaints

ClinicalTrials.gov processed this record on April 21, 2014