Postmenopausal SymptomsPhase 1/2NCT01170195
Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms
A Phase 1/2 study testing Calmera-Licorice Root Extract (Licogen) in people with Postmenopausal Symptoms and Vaginal Dryness, run by F&C Licorice Ltd at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Postmenopausal Symptoms, Vaginal Dryness
- What is being tested?
- Calmera-Licorice Root Extract (Licogen)
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva
Boris Kaplan, MD, 972-3-9377534, bkaplan@clalit.org.il
Boris Kaplan, MD
About this study
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.
Read the 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.
- Conditions
- Postmenopausal Symptoms, Vaginal Dryness
- Being tested
- Calmera-Licorice Root Extract (Licogen)
- Keywords
- Postmenopausal, licorice, vaginal complaints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calmera-Licorice Root Extract (Licogen)Dietary supplement
Also called Licogen
100 mg per day
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F&C Licorice Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Boris Kaplan, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170195
- Sponsor's protocol ID
- 5459
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms
- ClinicalTrials.gov ID
- NCT01170195
- Acronym / sponsor ID
- 5459
- Conditions
- Postmenopausal Symptoms, Vaginal Dryness
- Keywords
- Postmenopausal, licorice, vaginal complaints
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- F&C Licorice LtdUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calmera-Licorice Root Extract (Licogen)Also: Licogen100 mg per day | Dietary supplement | – |
Primary outcome
A beneficial effect of the licorice extract on postmenopausal symptoms (vasomotor symptoms, and nocturnal episodes) in symptomatic postmenopausal women
Time frame: 20 weeks
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
this objective will be measured by Pap Smear, Vaginal Ultra sound and vaginal PH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Kaplan, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Calmera-Licorice Root Extract (Licogen) in people with Postmenopausal Symptoms and Vaginal Dryness, run by F&C Licorice Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Kaplan, MD (972-3-9377534, bkaplan@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.