Status:
COMPLETED
Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms
Lead Sponsor:
EuroPharma, Inc.
Collaborating Sponsors:
I.Zhordania Institute of Reproductology
Conditions:
Menopause
Eligibility:
FEMALE
41+ years
Phase:
PHASE2
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 adul...
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03461380
Start Date
October 1 2018
End Date
October 1 2019
Last Update
April 28 2020
Active Locations (1)
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1
I.Zhordania Institute of Reproductology
Tbilisi, Georgia