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

Not Applicable

Completed

• Conditions: Perimenopause, Climacteric Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Amberen; Dietary Supplement: Smart B

• Registration Number: NCT03897738
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Study Start: 2019-04-30
• Status Verified: 2020-02
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amberen and Smart B	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.
Placebo	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.
Amberen and Smart B	Amberen	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.

Primary Outcome Measures

Name	Time	Method
"Panic attacks" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Crying spells" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Irritability" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Breathing difficulties" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Loss of interest in sex" symptom (Greene Climacteric Scale)	90 and 180 days	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"
"Feeling dizzy or faint" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Muscle or joint pains" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Increased Excitability" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Difficulty concentrating" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Headaches" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Difficulty sleeping" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Loss of interest in most things" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Feeling of sadness or depression" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Feeling tense or nervous" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Feeling tired or lacking energy" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
"Night sweats" symptom (Greene Climacteric Scale)	90 days and 180 days	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"
Blood plasma estradiol levels, pg/ml	90 and 180 days	Statistically significant changes in the levels, compared between arms
"Hot flushes" symptom (Greene Climacteric Scale)	90 days and 180 days	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"

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (State anxiety sub-scale)	90 and 180 days	Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
State-Trait Anxiety Inventory (Trait anxiety sub-scale)	90 and 180 days	Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Depression sub-score (measured by Hospital Anxiety and Depression Scale)	90 and 180 days	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
Well-being sub-score (Russian well-being, activity and mood questionnaire)	90 and 180 days	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.
State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales )	90 and 180 days	Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Mood sub-score (Russian well-being, activity and mood questionnaire)	90 and 180 days	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.
Anxiety sub-score (measured by Hospital Anxiety and Depression Scale)	90 and 180 days	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
Activity sub-score (Russian well-being, activity and mood questionnaire)	90 and 180 days	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.

Trial Locations

Locations (1)

Sechenov First Moscow Medical University; 🇷🇺 Moscow, Russian Federation