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

• ClinicalTrials.gov Identifier: NCT03897738
• Recruitment Status: Active, not recruiting
• First Posted: April 1, 2019
• Last Update Posted: August 26, 2019
• Sponsor: I.M. Sechenov First Moscow State Medical University
• Information provided by (Responsible Party): Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Perimenopause, Climacteric Syndrome	Dietary Supplement: Amberen; Dietary Supplement: Smart B; Dietary Supplement: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 30, 2019
• Estimated Primary Completion Date: December 1, 2019
• Estimated Study Completion Date: December 26, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) [ Time Frame: 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"
2. "Feeling tense or nervous" symptom (Greene Climacteric Scale) [ Time Frame: 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"
3. "Difficulty sleeping" symptom (Greene Climacteric Scale) [ Time Frame: 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"
4. "Increased Excitability" symptom (Greene Climacteric Scale) [ Time Frame: 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"
5. "Panic attacks" symptom (Greene Climacteric Scale) [ Time Frame: 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"
6. "Difficulty concentrating" symptom (Greene Climacteric Scale) [ Time Frame: 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"
7. "Feeling tired or lacking energy" symptom (Greene Climacteric Scale) [ Time Frame: 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"
8. "Loss of interest in most things" symptom (Greene Climacteric Scale) [ Time Frame: 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"
9. "Feeling of sadness or depression" symptom (Greene Climacteric Scale) [ Time Frame: 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"
10. "Crying spells" symptom (Greene Climacteric Scale) [ Time Frame: 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"
11. "Irritability" symptom (Greene Climacteric Scale) [ Time Frame: 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"
12. "Feeling dizzy or faint" symptom (Greene Climacteric Scale) [ Time Frame: 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"
13. "Pressure or tightness in head or body" symptom (Greene Climacteric Scale) [ Time Frame: 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"
14. "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale) [ Time Frame: 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"
15. "Headaches" symptom (Greene Climacteric Scale) [ Time Frame: 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"
16. "Muscle or joint pains" symptom (Greene Climacteric Scale) [ Time Frame: 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"
17. "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale) [ Time Frame: 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"
18. "Breathing difficulties" symptom (Greene Climacteric Scale) [ Time Frame: 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"
19. "Hot flushes" symptom (Greene Climacteric Scale) [ Time Frame: 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"
20. "Night sweats" symptom (Greene Climacteric Scale) [ Time Frame: 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"
21. "Loss of interest in sex" symptom (Greene Climacteric Scale) [ Time Frame: 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"
22. Blood plasma estradiol levels, pg/ml [ Time Frame: 90 and 180 days ]
    Statistically significant changes in the levels, compared between arms

Secondary Outcome Measures :

1. State-Trait Anxiety Inventory (State anxiety sub-scale) [ Time Frame: 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.
2. State-Trait Anxiety Inventory (Trait anxiety sub-scale) [ Time Frame: 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.
3. State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales ) [ Time Frame: 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.
4. Well-being sub-score (Russian well-being, activity and mood questionnaire) [ Time Frame: 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.
5. Activity sub-score (Russian well-being, activity and mood questionnaire) [ Time Frame: 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.
6. Mood sub-score (Russian well-being, activity and mood questionnaire) [ Time Frame: 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.
7. Anxiety sub-score (measured by Hospital Anxiety and Depression Scale) [ Time Frame: 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

8. Depression sub-score (measured by Hospital Anxiety and Depression Scale) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: up to 50 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Russian Federation

Sechenov First Moscow Medical University

Moscow, Russian Federation, 119991

Sponsors and Collaborators

I.M. Sechenov First Moscow State Medical University

More Information

• Responsible Party: Kuznetsova Irina, 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., I.M. Sechenov First Moscow State Medical University
• ClinicalTrials.gov Identifier: NCT03897738 History of Changes
• Other Study ID Numbers: AmberenSmartB-2019
• First Posted: April 1, 2019
• Last Update Posted: August 26, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University:

succinate; B complex vitamins; perimenopause

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes