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NCT03118908

Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome

Sponsored by I.M. Sechenov First Moscow State Medical University

Summary

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B by women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms.

Eligibility Criteria

Inclusion Criteria: * Female patients, 42-60 years of age; * Patient with diagnosis of "climacteric syndrome", in typical or non-complicated form, mild or moderate vegetative symptoms during menopause i.e. absence of menstrual period for at least 1 year; * Ability to read and understand informed consent form for the study's participation; * Patients without risk factors and changes in the breast tissue based on the mammogram; * Patients with medical history of risk factors without changes in the breast tissue; * Ability to adhere to the conditions of the study. Exclusion Criteria: * Presence of female reproductive system cancers (breast cancer, cervical cancer etc.); * Presence of extragenital oncological conditions, except those in complete remission for 5 years or more; * Conditions requiring emergency or planned hospitalization in the next 6 months; * Presence of hormonally-active extragenital endocrine diseases (thyroid, adrenal, pituitary, hypothalamus); * Surgical interventions done on sex organs or breasts, 1 year or less prior to the screening; * Any surgeries done less than 3 months prior to the screening; * Patients receiving HRT; * Psychiatric conditions; * Diabetes; * Total ovariectomy * Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the study * High risk of non-compliance

Locations (1)

Sechenov First Moscow Medical University

Moscow, Russia

Why you can trust this information
Registry sourcesclinicaltrials_gov
Source last updated10/20/2017
Clintriva indexed9/27/2026, 9:21:09 PM
Registry records1
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Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.

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Quick Facts
Start DateApr 24, 2017
CompletionOct 10, 2017
Enrollment0/107
CountryRussia

Conditions

Climacteric Syndrome
Menopause
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