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

NCT ID: NCT03897738

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2020-02-18

Brief Summary

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.

Detailed 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.

Conditions

Perimenopause, Climacteric Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Amberen and Smart B

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.

Group Type: EXPERIMENTAL

Amberen

Intervention Type: DIETARY_SUPPLEMENT

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

Smart B

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsules are identical to Amberen and Smart B capsules.

Interventions

Amberen

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

Intervention Type: DIETARY_SUPPLEMENT

Smart B

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsules are identical to Amberen and Smart B capsules.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kuznetsova Irina

Chief Researcher, Scientific Research Centre, Women's Health Scientific Research Department, I.M. Sechenov First Moscow State Medical University, University hospital #2, Obstetrics and Gynecology clinic.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sechenov First Moscow Medical University

Moscow, , Russia

Countries

Russia

References

Kachko VA, Shulman LP, Kuznetsova IV, Uspenskaya YB, Burchakov DI. Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen(R) and Smart B(R) in Women with Climacteric Syndrome in Perimenopause. Adv Ther. 2024 Aug;41(8):3183-3195. doi: 10.1007/s12325-024-02910-0. Epub 2024 Jun 21.

Reference Type: DERIVED

PMID: 38904899 (View on PubMed)

Other Identifiers

AmberenSmartB-2019

Identifier Type: -

Identifier Source: org_study_id