MenopausePhase 2NCT03461380
Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms
A Phase 2 study testing Menopause Relief EP-40, Low Dose Black Cohosh and High Dose Black Cohosh in people with Menopause, run by EuroPharma, Inc. at 1 site in Georgia.
Trial summary
This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints. Read more about this study
- Who is it for?
- Ages 41 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Menopause Relief EP-40, Low Dose Black Cohosh and High Dose Black Cohosh
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteGeorgia
- Study dates
- 1 Oct 2018to 1 Oct 2019
- Phase
- Phase 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 41 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of menopausal female climacteric states (N95.1 according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision, ICD-10, Version for 2014) which is characterized by symptoms such as flushing, sleeplessness, headache, lack of concentration associated with menopause, etc
- Patients suffering from menopausal syndrome with neurovegetative components which have been stable anamnestically during the last 2 weeks
- No medication taken for management of menopausal syndrome with neurovegetative components during the last 4 weeks
- Ability to understand and provide signed informed consent
- Ability to participate in the study
- In some cases, diagnosis should be confirmed by blood tests of follicle-stimulating hormone (≥ 40 IU/L) [postmenopausal status], thyroid function with normal serum free T4 (fT4), estrogen (estrodiol levels) [premenopausal 30-400 pg/mL; after menopause <30 pg/mL]
Who cannot join
- subjects with previous or current psychological disease that could interfere with their ability to participate in the study
- anamnestic or current alcohol or drug abuse
- concomitant treatment with psychotropic (in particular benzodiazepines, antidepressants, hypnotics or neuroleptics, tamoxifen, clomiphene, and danazol) or hormonally acting drugs such as hormone replacement therapy (HRT)
- hyperthyroidism
- malignant tumors
- continuous climacteric bleeding and complaints related to myomas
Show all 13Show fewer
- patients who have taken another experimental drug within a 4-week period prior to the trial
- pregnancy/lactation
- serious internal disease
- previous organ transplantation
- premenopausal women with insufficient contraceptive protection
- hypersensitivity to one of the ingredients of the trial medication
- a body mass index of >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Menopause Relief EP-40 - Fixed Combination of Cimicifuga EP-40 and Rhodiola EPR-7 Extracts in Women With Menopausal Symptoms: A Randomized, Double Blind, Placebo Controlled Study
This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints.
Read the detailed description
Due to the problems caused by Hormone Replacement Therapy with chemical entities, some medicinal plants used in the traditional systems of medicine have shown immense potential in non-hormonal treatment of menopausal symptoms without major adverse events. We hypothesize that Menopause Relief EP-40 (a fixed combination of Cimicifuga EP-40 and Rhodiola EPR-7 extracts) will significantly relieve menopausal complaints such as hot flushes, profuse sweating hot flushes, excessive perspiration, night sweats, sleep disorders, nervousness, mood swings, physical and mental fatigue as compared to EP-40® capsules or placebo in adult females in menopause.
- Conditions
- Menopause
- Being tested
- Menopause Relief EP-40, Low Dose Black Cohosh, High Dose Black Cohosh, Placebo
- Keywords
- Cimicifuga, Rhodiola, Menopause Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopause Relief EP-40Dietary supplement
Fixed combination of black cohosh and Rhodiola rosea
Low Dose Black CohoshDietary supplement
6.5 mg black cohosh
High Dose Black CohoshDietary supplement
500 mg black cohosh
PlaceboDietary supplement
600 mg excipient
| Study group | Role | What they receive |
|---|---|---|
| Menopause Relief EP-40 | Experimental | Fixed combination of black cohosh EP-40 and Rhodiola rosea EPR-7 206.5 mg orally twice daily; daily dose 413 mg of active ingredients Receives: Dietary Supplement: Menopause Relief EP-40 |
| High Dose Black Cohosh | Active comparator | Black cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient Receives: Dietary Supplement: High Dose Black Cohosh |
| Placebo | Placebo comparator | Placebo capsule 600 mg excipients orally twice daily Receives: Dietary Supplement: Placebo |
| Low Dose Black Cohosh | Active comparator | Black cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient Receives: Dietary Supplement: Low Dose Black Cohosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kupperman Menopausal Index (KMI)
A modified total Kupperman Index (KMI) score and its sub-items will be used. It is a 10-item questionnaire of single symptoms with scores ranging from 0 to 3 (none, mild, moderate and severe). Total KMI is defined as the sum of sub-item scores multiplied by any weighting factors. The maximum value of the total KMI is 48. The primary outcome will be the difference in the changes from baseline to the end of therapy (week 12), between verum groups and placebo, assessed by the total KMI and stratified by individual baseline scores in an intention-to-treat (ITT) analysis (patients treated with study medication and with at least one efficacy assessment after baseline).
Measured: 12 weeks
Menopause Rating Scale (MRS)
The MRS is a patient reported assessment of 11 symptoms of menopause on a scale of 0 (none) to 4 (very severe). The MRS groups symptoms into three subscales: psychological, somatic, and urogenital. A composite score is calculated by adding the items in each dimension (subscale). The total score is the sum of the three dimensional scores. The primary outcome will be the difference in the changes from baseline to the end of therapy (week 12), between both verum groups and placebo, assessed by the MRS and stratified by individual baseline scores in an intention-to-treat (ITT) analysis (patients treated with study medication and with at least one efficacy assessment after baseline).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- I.Zhordania Institute of Reproductology
- Responsible party
- Sponsor
- Investigators
- Lali Phkhaladze, PhD, MD, Principal investigator, I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461380
- Sponsor's protocol ID
- EP-1002
- Other IDs
- EP-2018-1
- Status last verified
- Apr 2020
- First submitted
- 2 Mar 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Menopause Relief EP-40 - Fixed Combination of Cimicifuga EP-40 and Rhodiola EPR-7 Extracts in Women With Menopausal Symptoms: A Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03461380
- Acronym / sponsor ID
- EP-1002
- Conditions
- Menopause
- Keywords
- Cimicifuga, Rhodiola, Menopause Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- I.Zhordania Institute of Reproductology
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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.
This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints.
Detailed description
Due to the problems caused by Hormone Replacement Therapy with chemical entities, some medicinal plants used in the traditional systems of medicine have shown immense potential in non-hormonal treatment of menopausal symptoms without major adverse events. We hypothesize that Menopause Relief EP-40 (a fixed combination of Cimicifuga EP-40 and Rhodiola EPR-7 extracts) will significantly relieve menopausal complaints such as hot flushes, profuse sweating hot flushes, excessive perspiration, night sweats, sleep disorders, nervousness, mood swings, physical and mental fatigue as compared to EP-40® capsules or placebo in adult females in menopause.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menopause Relief EP-40 | Experimental | Dietary Supplement: Menopause Relief EP-40Fixed combination of black cohosh EP-40 and Rhodiola rosea EPR-7 206.5 mg orally twice daily; daily dose 413 mg of active ingredients |
| High Dose Black Cohosh | Active comparator | Dietary Supplement: High Dose Black CohoshBlack cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule 600 mg excipients orally twice daily |
| Low Dose Black Cohosh | Active comparator | Dietary Supplement: Low Dose Black CohoshBlack cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient |
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of menopausal female climacteric states (N95.1 according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision, ICD-10, Version for 2014) which is characterized by symptoms such as flushing, sleeplessness, headache, lack of concentration associated with menopause, etc
- Patients suffering from menopausal syndrome with neurovegetative components which have been stable anamnestically during the last 2 weeks
- No medication taken for management of menopausal syndrome with neurovegetative components during the last 4 weeks
- Ability to understand and provide signed informed consent
- Ability to participate in the study
Key exclusion criteria (13 listed)
- subjects with previous or current psychological disease that could interfere with their ability to participate in the study
- anamnestic or current alcohol or drug abuse
- concomitant treatment with psychotropic (in particular benzodiazepines, antidepressants, hypnotics or neuroleptics, tamoxifen, clomiphene, and danazol) or hormonally acting drugs such as hormone replacement therapy (HRT)
- hyperthyroidism
- malignant tumors
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 |
|---|---|---|
| Menopause Relief EP-40Fixed combination of black cohosh and Rhodiola rosea | Dietary supplement | Menopause Relief EP-40 |
| Low Dose Black Cohosh6.5 mg black cohosh | Dietary supplement | Low Dose Black Cohosh |
| High Dose Black Cohosh500 mg black cohosh | Dietary supplement | High Dose Black Cohosh |
| Placebo600 mg excipient | Dietary supplement | Placebo |
Primary outcome
Kupperman Menopausal Index (KMI)
Time frame: 12 weeks
A modified total Kupperman Index (KMI) score and its sub-items will be used. It is a 10-item questionnaire of single symptoms with scores ranging from 0 to 3 (none, mild, moderate and severe). Total KMI is defined as the sum of sub-item scores multiplied by any weighting factors. The maximum value of the total KMI is 48. The primary outcome will be the difference in the changes from baseline to the end of therapy (week 12), between verum groups and placebo, assessed by the total KMI and stratified by individual baseline scores in an intention-to-treat (ITT) analysis (patients treated with study medication and with at least one efficacy assessment after baseline).
Menopause Rating Scale (MRS)
Time frame: 12 weeks
The MRS is a patient reported assessment of 11 symptoms of menopause on a scale of 0 (none) to 4 (very severe). The MRS groups symptoms into three subscales: psychological, somatic, and urogenital. A composite score is calculated by adding the items in each dimension (subscale). The total score is the sum of the three dimensional scores. The primary outcome will be the difference in the changes from baseline to the end of therapy (week 12), between both verum groups and placebo, assessed by the MRS and stratified by individual baseline scores in an intention-to-treat (ITT) analysis (patients treated with study medication and with at least one efficacy assessment after baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Lali Phkhaladze, PhD, MD principal investigator
I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Menopause Relief EP-40, Low Dose Black Cohosh and High Dose Black Cohosh in people with Menopause, run by EuroPharma, Inc. at 1 site in Georgia.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 28 Apr 2020. 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 Georgia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kupperman Menopausal Index (KMI) (time frame: 12 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 28 Apr 2020.