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Trial record 1 of 1 for:    NCT03461380 | "Menopause"
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Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461380
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
I.Zhordania Institute of Reproductology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Menopause Dietary Supplement: Menopause Relief EP-40 Dietary Supplement: Low Dose Black Cohosh Dietary Supplement: High Dose Black Cohosh Dietary Supplement: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461380


Locations
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Georgia
I.Zhordania Institute of Reproductology
Tbilisi, Georgia
Sponsors and Collaborators
EuroPharma, Inc.
I.Zhordania Institute of Reproductology
Investigators
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Principal Investigator: Lali Phkhaladze, PhD, MD I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia
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Responsible Party: EuroPharma, Inc.
ClinicalTrials.gov Identifier: NCT03461380    
Other Study ID Numbers: EP-1002
EP-2018-1 ( Other Identifier: Sponsor )
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EuroPharma, Inc.:
Cimicifuga, Rhodiola, Menopause Symptoms