Perimenopause, Climacteric SyndromeNCT03897738
Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.
A study testing Amberen and Smart B in people with Perimenopause, Climacteric Syndrome, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages Up to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Climacteric Syndrome
- What is being tested?
- Amberen and Smart B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteRussia
- Study dates
- 30 Apr 2019to 18 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- • 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- 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.
- Conditions
- Perimenopause, Climacteric Syndrome
- Being tested
- Amberen, Smart B, Placebo
- Keywords
- succinate, B complex vitamins, perimenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmberenDietary supplement
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
Smart BDietary supplement
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
PlaceboDietary supplement
Placebo capsules are identical to Amberen and Smart B capsules.
| Study group | Role | What they receive |
|---|---|---|
| Amberen and Smart B | Experimental | 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. Receives: Dietary Supplement: Amberen; Dietary Supplement: Smart B |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 days and 180 days
"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"
Measured: 90 and 180 days
Blood plasma estradiol levels, pg/ml
Statistically significant changes in the levels, compared between arms
Measured: 90 and 180 days
Secondary outcomes (8)
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.
Measured: 90 and 180 days
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.
Measured: 90 and 180 days
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.
Measured: 90 and 180 days
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.
Measured: 90 and 180 days
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.
Measured: 90 and 180 days
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.
Measured: 90 and 180 days
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
Measured: 90 and 180 days
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
Measured: 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start30 Apr 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perimenopause, Climacteric SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897738
- Sponsor's protocol ID
- AmberenSmartB-2019
- Status last verified
- Feb 2020
- First submitted
- 27 Mar 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kachko VA, Shulman LP, Kuznetsova IV, Uspenskaya YB, Burchakov DI. Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen(R) and Smart B(R) in Women with Climacteric Syndrome in Perimenopause. Adv Ther. 2024 Aug;41(8):3183-3195. doi: 10.1007/s12325-024-02910-0. Epub 2024 Jun 21.
PubMed 38904899
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03897738
- Acronym / sponsor ID
- AmberenSmartB-2019
- Conditions
- Perimenopause, Climacteric Syndrome
- Keywords
- succinate, B complex vitamins, perimenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amberen and Smart B | Experimental | Dietary Supplement: Amberen, Dietary Supplement: Smart BAmberen - 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female subjects, 50 years of age or younger;
Key exclusion criteria (13 listed)
- • Postmenopause, including surgical menopause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmberenAmberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms. | Dietary supplement | Amberen and Smart B |
| Smart BSmart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate. | Dietary supplement | Amberen and Smart B |
| PlaceboPlacebo capsules are identical to Amberen and Smart B capsules. | Dietary supplement | Placebo |
Primary outcome
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
"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"
Blood plasma estradiol levels, pg/ml
Time frame: 90 and 180 days
Statistically significant changes in the levels, compared between arms
8 secondary outcomes
State-Trait Anxiety Inventory (State anxiety sub-scale)
Time frame: 90 and 180 days
State-Trait Anxiety Inventory (Trait anxiety sub-scale)
Time frame: 90 and 180 days
State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales )
Time frame: 90 and 180 days
Well-being sub-score (Russian well-being, activity and mood questionnaire)
Time frame: 90 and 180 days
Activity sub-score (Russian well-being, activity and mood questionnaire)
Time frame: 90 and 180 days
Mood sub-score (Russian well-being, activity and mood questionnaire)
Time frame: 90 and 180 days
Anxiety sub-score (measured by Hospital Anxiety and Depression Scale)
Time frame: 90 and 180 days
Depression sub-score (measured by Hospital Anxiety and Depression Scale)
Time frame: 90 and 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 38904899Kachko VA, Shulman LP, Kuznetsova IV, Uspenskaya YB, Burchakov DI. Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen(R) and Smart B(R) in Women with Climacteric Syndrome in Perimenopause. Adv Ther. 2024 Aug;41(8):3183-3195. doi: 10.1007/s12325-024-02910-0. Epub 2024 Jun 21.
- Individual participant dataSharing planned: No
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Perimenopause, Perimenopausal Women
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Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amberen and Smart B in people with Perimenopause, Climacteric Syndrome, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale) (time frame: 90 days and 180 days). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03897738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.