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

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Perimenopause, Climacteric Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Amberen; Dietary Supplement: Smart B

Study type: Interventional

Funder types: Other

Identifiers

NCT03897738

AmberenSmartB-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: Female

Ages: Under 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups, including a placebo group

Amberen and Smart B

Experimental group

Description:

Amberen - a dietary supplement: 2 capsules (one while capsule 200 mg and one orange capsule 200 mg) are taken once a day with a meal, preferably after breakfast, for 3 months. SMART В - a dietary supplement: 1 capsule per day (166 mg) is taken once a day with a meal, preferably after breakfast, for 3 months, concurrently with Amberen.

Treatment:

Dietary Supplement: Amberen

Dietary Supplement: Smart B

Placebo

Placebo Comparator group

Description:

Placebo is taken as follows: 3 capsules (one while capsule 200 mg, one orange capsule 200 mg, one capsule 166mg) are taken once a day with a meal, preferably after breakfast, for 3 months. Placebo capsules are identical to Amberen and Smart B capsules.

Treatment:

Dietary Supplement: Placebo