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Completed

NCT Number: NCT03461380

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

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.

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Key information

Conditions

Menopause

Age range

41 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

I.Zhordania Institute of Reproductology

Tbilisi, Georgia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menopause Relief EP-40

Dietary Supplement

Fixed combination of black cohosh and Rhodiola rosea

Low Dose Black Cohosh

Dietary Supplement

6.5 mg black cohosh

High Dose Black Cohosh

Dietary Supplement

500 mg black cohosh

Placebo

Dietary Supplement

600 mg excipient

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

EuroPharma, Inc.

Industry

Collaborators

  • I.Zhordania Institute of Reproductology

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2018
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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