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
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.
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
Sechenov First Moscow Medical University
Moscow, Russia
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
Interested in this trial?
Express your interest and we'll connect you with the trial team.
Your selected profile and contact information may be shared with an authorised trial site, sponsor, or Clintriva coordination team for trial contact and pre-screening. Expressing interest does not mean you are eligible or enrolled.
Conditions