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

NCT01170195 | Unknown Phase 1

• 1 other identifier: 5459
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Symptoms; Vaginal Dryness

Keywords

Postmenopausal; licorice; vaginal complaints

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Calmera-Licorice Root Extract (Licogen) DIETARY_SUPPLEMENT

100 mg per day

Also known as: Licogen

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages 45-60,
• Who are post-menopausal (proved by a laboratory test of FSH \> 30 International units),
• 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).

You may not qualify if:

• Female patients who are outside the age boundaries of 45-60,
• Have FSH \<30
• Patients who presently have cancer of any kind,
• Patients that are on any other treatment for relieving post-menopausal symptoms
• Patients who have contraindication to Licorice.

Sponsors & Collaborators

• F&C Licorice Ltd: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Study Officials

• Boris Kaplan, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Kaplan, MD

CONTACT

972-3-9377534; bkaplan@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 27, 2010

Record last verified: 2010-07

Locations

IL (1)