Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms
NCT ID: NCT03461380
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2018-10-01
2019-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Menopause Relief EP-40
Fixed combination of black cohosh and Rhodiola rosea
High Dose Black Cohosh
Black cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient
High Dose Black Cohosh
500 mg black cohosh
Placebo
Placebo capsule 600 mg excipients orally twice daily
Placebo
600 mg excipient
Low Dose Black Cohosh
Black cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient
Low Dose Black Cohosh
6.5 mg black cohosh
Interventions
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Menopause Relief EP-40
Fixed combination of black cohosh and Rhodiola rosea
Low Dose Black Cohosh
6.5 mg black cohosh
High Dose Black Cohosh
500 mg black cohosh
Placebo
600 mg excipient
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
41 Years
FEMALE
Yes
Sponsors
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I.Zhordania Institute of Reproductology
UNKNOWN
EuroPharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lali Phkhaladze, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia
Locations
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I.Zhordania Institute of Reproductology
Tbilisi, , Georgia
Countries
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Other Identifiers
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EP-2018-1
Identifier Type: OTHER
Identifier Source: secondary_id
EP-1002
Identifier Type: -
Identifier Source: org_study_id
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