Perimenopause, Climacteric Syndrome Clinical Trial
Official title:
Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause
| Verified date | February 2020 |
| Source | I.M. Sechenov First Moscow State Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | February 18, 2020 |
| Est. primary completion date | February 18, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A to 50 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Sechenov First Moscow Medical University | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| I.M. Sechenov First Moscow State Medical University |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | "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 | |
| Primary | Blood plasma estradiol levels, pg/ml | Statistically significant changes in the levels, compared between arms | 90 and 180 days | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |