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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461380
• Other study ID #: EP-1002
• Secondary ID: EP-2018-1
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: April 2020
• Source: EuroPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 1, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• Menopause Relief EP-40
Fixed combination of black cohosh and Rhodiola rosea
• Low Dose Black Cohosh
6.5 mg black cohosh
• High Dose Black Cohosh
500 mg black cohosh
• Placebo
600 mg excipient

Locations

Country	Name	City	State
Georgia	I.Zhordania Institute of Reproductology	Tbilisi

Sponsors (2)

Lead Sponsor	Collaborator
EuroPharma, Inc.	I.Zhordania Institute of Reproductology

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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