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

Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause

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.

Study Overview

• Status: Completed
• Conditions: Perimenopause, Climacteric Syndrome
• Intervention / Treatment: Dietary supplement: Amberen; Dietary supplement: Smart B; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Sechenov First Moscow Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Amberen; Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.; Dietary supplement: Smart B; Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
Placebo Comparator: 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.	Dietary supplement: Placebo; Placebo capsules are identical to Amberen and Smart B capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory (State anxiety sub-scale)	Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.	90 and 180 days
State-Trait Anxiety Inventory (Trait anxiety sub-scale)	Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.	90 and 180 days
State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales )	Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.	90 and 180 days
Well-being sub-score (Russian well-being, activity and mood questionnaire)	Statistically significant change in designated symptom severity, compared between arms. The sub-scale score varies from 10 to 70 points, with the higher score corresponding to more positive self-evaluation of well-being.	90 and 180 days
Activity sub-score (Russian well-being, activity and mood questionnaire)	Statistically significant change in designated symptom severity, compared between arms. The sub-scale score varies from 10 to 70 points, with the higher score corresponding to more positive self-evaluation of one's activity.	90 and 180 days
Mood sub-score (Russian well-being, activity and mood questionnaire)	Statistically significant change in designated symptom severity, compared between arms. The sub-scale score varies from 10 to 70 points, with the higher score corresponding to more positive self-evaluation of one's mood.	90 and 180 days
Anxiety sub-score (measured by Hospital Anxiety and Depression Scale)	Statistically significant change in designated symptom severity, compared between arms. The scores range from 0 to 21. 0-7 = Normal 8-10 = Borderline abnormal 11-21 = Abnormal	90 and 180 days
Depression sub-score (measured by Hospital Anxiety and Depression Scale)	Statistically significant change in designated symptom severity, compared between arms. The scores range from 0 to 21. 0-7 = Normal 8-10 = Borderline abnormal 11-21 = Abnormal	90 and 180 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): February 18, 2020
• Study Completion (Actual): February 18, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: B complex vitamins; perimenopause; succinate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: AmberenSmartB-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No