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

July 26, 2010
July 26, 2010
September 2010
September 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postmenopausal Symptoms
  • Vaginal Dryness
Dietary Supplement: Calmera-Licorice Root Extract (Licogen)
100 mg per day
Other Name: Licogen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Female
45 Years to 60 Years
No
Contact: Boris Kaplan, MD 972-3-9377534 bkaplan@clalit.org.il
Israel
 
NCT01170195
5459
No
Nir Kedem, F&C Licorice Ltd
F&C Licorice Ltd
Not Provided
Principal Investigator: Boris Kaplan, MD Rabin Medical Center
F&C Licorice Ltd
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP