Clinical trial NCT03897738: Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perimenopause, Climacteric Syndrome
Keywords: succinate
B complex vitamins
perimenopause
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 106
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: "Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Feeling tense or nervous" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Difficulty sleeping" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Increased Excitability" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Panic attacks" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Difficulty concentrating" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Feeling tired or lacking energy" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Loss of interest in most things" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Feeling of sadness or depression" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Crying spells" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Irritability" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Feeling dizzy or faint" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Headaches" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Muscle or joint pains" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Breathing difficulties" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Hot flushes" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Night sweats" symptom (Greene Climacteric Scale)
timeFrame: 90 days and 180 days
measure: "Loss of interest in sex" symptom (Greene Climacteric Scale)
timeFrame: 90 and 180 days
measure: Blood plasma estradiol levels, pg/ml
timeFrame: 90 and 180 days
Secondary outcomes:
measure: State-Trait Anxiety Inventory (State anxiety sub-scale)
timeFrame: 90 and 180 days
measure: State-Trait Anxiety Inventory (Trait anxiety sub-scale)
timeFrame: 90 and 180 days
measure: State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales )
timeFrame: 90 and 180 days
measure: Well-being sub-score (Russian well-being, activity and mood questionnaire)
timeFrame: 90 and 180 days
measure: Activity sub-score (Russian well-being, activity and mood questionnaire)
timeFrame: 90 and 180 days
measure: Mood sub-score (Russian well-being, activity and mood questionnaire)
timeFrame: 90 and 180 days
measure: Anxiety sub-score (measured by Hospital Anxiety and Depression Scale)
timeFrame: 90 and 180 days
measure: Depression sub-score (measured by Hospital Anxiety and Depression Scale)
timeFrame: 90 and 180 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov First Moscow Medical University
Study officials:
References: