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OpenTrials
Completed

NCT Number: NCT03897738

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

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.

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Key information

Conditions

Perimenopause, Climacteric Syndrome

Age range

Up to 50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sechenov First Moscow Medical University

Moscow, 119991, Russia

About this study

  • To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B in women vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amberen

Dietary Supplement

Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.

Smart B

Dietary Supplement

Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.

Placebo

Dietary Supplement

Placebo capsules are identical to Amberen and Smart B capsules.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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