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

Phase 2

Completed

• Conditions: Menopause
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Menopause Relief EP-40; Dietary Supplement: High Dose Black Cohosh; Dietary Supplement: Low Dose Black Cohosh

• Registration Number: NCT03461380
• Lead Sponsor: EuroPharma, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Study Start: 2018-10-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule 600 mg excipients orally twice daily
Menopause Relief EP-40	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
High Dose Black Cohosh	High Dose Black Cohosh	Black cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient
Low Dose Black Cohosh	Low Dose Black Cohosh	Black cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient

Primary Outcome Measures

Name	Time	Method
Kupperman Menopausal Index (KMI)	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)	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).

Trial Locations

Locations (1)

I.Zhordania Institute of Reproductology; 🇬🇪 Tbilisi, Georgia