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

NCT03461380 | Completed Phase 2

• 2 other identifiers: EP-1002EP-2018-1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Cimicifuga, Rhodiola, Menopause Symptoms

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Menopause Relief EP-40

EXPERIMENTAL

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

High Dose Black Cohosh

ACTIVE COMPARATOR

Black cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient

Dietary Supplement: High Dose Black Cohosh

Placebo

PLACEBO COMPARATOR

Placebo capsule 600 mg excipients orally twice daily

Dietary Supplement: Placebo

Low Dose Black Cohosh

ACTIVE COMPARATOR

Black cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient

Dietary Supplement: Low Dose Black Cohosh

Interventions

Menopause Relief EP-40 DIETARY_SUPPLEMENT

Fixed combination of black cohosh and Rhodiola rosea

Menopause Relief EP-40

Low Dose Black Cohosh DIETARY_SUPPLEMENT

6.5 mg black cohosh

Low Dose Black Cohosh

High Dose Black Cohosh DIETARY_SUPPLEMENT

500 mg black cohosh

High Dose Black Cohosh

Placebo DIETARY_SUPPLEMENT

600 mg excipient

Placebo

Eligibility Criteria

• Age: 41 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[premenopausal 30-400 pg/mL; after menopause \<30 pg/mL\]

You may not qualify if:

• 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

Sponsors & Collaborators

• EuroPharma, Inc.: lead
• I.Zhordania Institute of Reproductology: collaborator

Study Sites (1)

I.Zhordania Institute of Reproductology

Tbilisi, Georgia

Location

MeSH Terms

Interventions

black cohosh root extract

Study Officials

• Lali Phkhaladze, PhD, MD

  I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 12, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 1, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)