Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: Menopause Relief EP-40; Dietary supplement: High Dose Black Cohosh; Dietary supplement: Placebo; Dietary supplement: Low Dose Black Cohosh

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • I.Zhordania Institute of Reproductology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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]

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menopause Relief EP-40; 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	Dietary supplement: Menopause Relief EP-40; Fixed combination of black cohosh and Rhodiola rosea
Active Comparator: High Dose Black Cohosh; Black cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient	Dietary supplement: High Dose Black Cohosh; 500 mg black cohosh
Placebo Comparator: Placebo; Placebo capsule 600 mg excipients orally twice daily	Dietary supplement: Placebo; 600 mg excipient
Active Comparator: Low Dose Black Cohosh; Black cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient	Dietary supplement: Low Dose Black Cohosh; 6.5 mg black cohosh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	12 weeks

Collaborators and Investigators

• Sponsor: EuroPharma, Inc.
• Collaborators: I.Zhordania Institute of Reproductology
• Investigators: Principal Investigator: Lali Phkhaladze, PhD, MD, I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cimicifuga, Rhodiola, Menopause Symptoms
• Other Study ID Numbers: EP-1002; EP-2018-1 (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No