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CompletedNCT03897738Updated Feb 20, 2020

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

An interventional study of Amberen and Smart B in Perimenopause, Climacteric Syndrome, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russian Federation. Open to female participants aged Up to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
Up to 50 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Perimenopause, Climacteric Syndrome

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Keywords

  • succinate
  • B complex vitamins
  • perimenopause
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 106 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
106 participants (actual)

Study arms

  • 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 · Dietary Supplement: Smart B

  • 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

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.

06

What researchers measure

Primary outcomes

  1. "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"

    Time frame: 90 days and 180 days

  2. "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"

    Time frame: 90 days and 180 days

  3. "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"

    Time frame: 90 days and 180 days

  4. "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"

    Time frame: 90 days and 180 days

  5. "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"

    Time frame: 90 days and 180 days

  6. "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"

    Time frame: 90 days and 180 days

  7. "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"

    Time frame: 90 days and 180 days

  8. "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"

    Time frame: 90 days and 180 days

  9. "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"

    Time frame: 90 days and 180 days

  10. "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"

    Time frame: 90 days and 180 days

  11. "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"

    Time frame: 90 days and 180 days

  12. "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"

    Time frame: 90 days and 180 days

  13. "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"

    Time frame: 90 days and 180 days

  14. "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"

    Time frame: 90 days and 180 days

  15. "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"

    Time frame: 90 days and 180 days

  16. "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"

    Time frame: 90 days and 180 days

  17. "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"

    Time frame: 90 days and 180 days

  18. "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"

    Time frame: 90 days and 180 days

  19. "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"

    Time frame: 90 days and 180 days

  20. "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"

    Time frame: 90 days and 180 days

  21. "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"

    Time frame: 90 and 180 days

  22. Blood plasma estradiol levels, pg/ml

    Statistically significant changes in the levels, compared between arms

    Time frame: 90 and 180 days

Secondary outcomes

  1. 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.

    Time frame: 90 and 180 days

  2. 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.

    Time frame: 90 and 180 days

  3. 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.

    Time frame: 90 and 180 days

  4. 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.

    Time frame: 90 and 180 days

  5. 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.

    Time frame: 90 and 180 days

  6. 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.

    Time frame: 90 and 180 days

  7. 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

    Time frame: 90 and 180 days

  8. 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

    Time frame: 90 and 180 days

07

Study locations

1 site
  • Sechenov First Moscow Medical University
    Moscow, 119991, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03897738
Lead sponsor
I.M. Sechenov First Moscow State Medical University
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) — Principal investigator
First posted
Apr 1, 2019
Start date
Apr 30, 2019
Primary completion
Feb 18, 2020
Completion
Feb 18, 2020
Last update
Feb 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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