Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.

I.M. Sechenov First Moscow State Medical University106 enrolled

Overview

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

1. To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B in women vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause. 2. To evaluate safety of combined use of dietary supplements Amberen and Smart B in women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause. 3. To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

106

Conditions

Perimenopause, Climacteric Syndrome

Interventions

AmberenDIETARY_SUPPLEMENT

Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.

Smart BDIETARY_SUPPLEMENT

Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.

PlaceboDIETARY_SUPPLEMENT

Placebo capsules are identical to Amberen and Smart B capsules.

Eligibility

Sex: FEMALEMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female subjects, 50 years of age or younger; * Subjects in the second phase of menopausal transition as per STRAW 10+ i.e. interval of amenorrhea 60 days or more (with regular menstrual cycle during earlier reproductive stages). * Subjects with diagnosis of mild to moderate climacteric syndrome; * Recent (up to 12 months prior to study enrollment) breast exam results, including mammogram, that rule out malignancies; * Recent (up to 3 years prior to study enrollment) cytological screening that rules out vaginal cervix malignancies. * Ability to read and understand informed consent form for the study's participation; * Ability to adhere to the conditions of the study. Exclusion Criteria: * • Postmenopause, including surgical menopause. * Presence of hormone-dependent cancers; * Presence of other cancers, not in full remission with no recurrence for 5 years or more; * Planned hospitalization in the next 6 months; * Presence of hormonally-active extragenital endocrine diseases (diabetes; diseases of thyroid, adrenal, pituitary) that require prolonged or life-long therapies * Surgical interventions on sex organs or breasts, 1 year or less prior to the screening; * Gynecological conditions that may require hormonal therapies or surgeries (uterine myoma, endometriosis, endometrial hyperplasia etc.); * Currently undergoing or planning to utilize assisted reproductive technologies; * Any abdominal surgeries within less than 3 months prior to the screening; * HRT including MHRT or hormonal contraceptives - current or within less than 3 months prior to the screening; * Psychiatric conditions; * Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the trial; * High risk of non-compliance.

Locations (1)

Sechenov First Moscow Medical University

Moscow, Russia

Outcomes

Primary Outcomes

"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)

Statistically significant change in designated symptom severity, compared between arms. This is question 1 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"