Perimenopause, Climacteric Syndrome
Conditions
Keywords
succinate, B complex vitamins, perimenopause
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.
Interventions
DIETARY_SUPPLEMENTAmberen
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
DIETARY_SUPPLEMENTSmart B
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
DIETARY_SUPPLEMENTPlacebo
Placebo capsules are identical to Amberen and Smart B capsules.
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood plasma estradiol levels, pg/ml | 90 and 180 days | Statistically significant changes in the levels, compared between arms |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
Countries
Russia
Outcome results
None listed