Clinical trial NCT01170195: Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms
Official title: Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postmenopausal Symptoms
Vaginal Dryness
Keywords: Postmenopausal
licorice
vaginal complaints
Lead sponsor: F&C Licorice Ltd
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: A beneficial effect of the licorice extract on postmenopausal symptoms (vasomotor symptoms, and nocturnal episodes) in symptomatic postmenopausal women
timeFrame: 20 weeks
measure: A beneficial effect of the licorice extract on vaginal complaints in symptomatic postmenopausal women
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Boris Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References: