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

NCT03897738 | Completed

• 1 other identifier: AmberenSmartB-2019
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopause, Climacteric Syndrome

Keywords

succinate; B complex vitamins; perimenopause

Outcome Measures

Primary Outcomes (22)

• "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"

  90 days and 180 days

• "Feeling tense or nervous" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 2 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"

  90 days and 180 days

• "Difficulty sleeping" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 3 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"

  90 days and 180 days

• "Increased Excitability" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 4 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"

  90 days and 180 days

• "Panic attacks" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 5 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"

  90 days and 180 days

• "Difficulty concentrating" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 6 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"

  90 days and 180 days

• "Feeling tired or lacking energy" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 7 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"

  90 days and 180 days

• "Loss of interest in most things" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 8 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"

  90 days and 180 days

• "Feeling of sadness or depression" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 9 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"

  90 days and 180 days

• "Crying spells" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 10 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"

  90 days and 180 days

• "Irritability" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 11 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"

  90 days and 180 days

• "Feeling dizzy or faint" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 12 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"

  90 days and 180 days

• "Pressure or tightness in head or body" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 13 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"

  90 days and 180 days

• "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 14 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"

  90 days and 180 days

• "Headaches" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 15 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"

  90 days and 180 days

• "Muscle or joint pains" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 16 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"

  90 days and 180 days

• "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 17 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"

  90 days and 180 days

• "Breathing difficulties" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 18 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"

  90 days and 180 days

• "Hot flushes" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 19 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"

  90 days and 180 days

• "Night sweats" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 20 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"

  90 days and 180 days

• "Loss of interest in sex" symptom (Greene Climacteric Scale)

  Statistically significant change in designated symptom severity, compared between arms. This is question 21 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"

  90 and 180 days

• Blood plasma estradiol levels, pg/ml

  Statistically significant changes in the levels, compared between arms

  90 and 180 days

Secondary Outcomes (8)

• State-Trait Anxiety Inventory (State anxiety sub-scale)

  90 and 180 days

• State-Trait Anxiety Inventory (Trait anxiety sub-scale)

  90 and 180 days

• State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales )

  90 and 180 days

• Well-being sub-score (Russian well-being, activity and mood questionnaire)

  90 and 180 days

• Activity sub-score (Russian well-being, activity and mood questionnaire)

  90 and 180 days

Study Arms (2)

Amberen and Smart B

EXPERIMENTAL

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.

Dietary Supplement: Amberen; Dietary Supplement: Smart B

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Amberen DIETARY_SUPPLEMENT

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

Amberen and Smart B

Smart B DIETARY_SUPPLEMENT

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

Amberen and Smart B

Placebo DIETARY_SUPPLEMENT

Placebo capsules are identical to Amberen and Smart B capsules.

Placebo

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov First Moscow Medical University

Moscow, 119991, Russia

Location

Related Publications (1)

• 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.

  PMID: 38904899 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: April 30, 2019
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)