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To obtain new data allowing personalizing continuous hormonal therapy in perimenopausal women in Russia, the following clinical study is going to be conducted in the Russian Federation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-dose Combination (FDC) estradiol / dydrogesterone | Experimental | Femoston® 1 (1 mg estradiol / 10 mg dydrogesterone), Femoston® 2 (2 mg estradiol / 10 mg dydrogesterone) |
|
| Combination therapy with estradiol and dydrogesterone | Active Comparator | Duphaston®, 10 mg and Divigel, 0.1% |
|
| non-hormonal therapy | Active Comparator | Cimicifuga racemosa rhizomatum extract (Klimadynon®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoston® 1, Femoston® 2 | Drug | Femoston® 1 (1 mg estradiol / 10 mg dydrogesterone), Femoston® 2 (2 mg estradiol / 10 mg dydrogesterone) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the average number of "hot flashes" per day* as percentages according to data from the patient diary after 84 days (3 cycles) since the initiation of treatment compared to baseline (Visit 0). | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the total score on the Greene Climacteric Scale at the end of the therapy (364 days) compared to baseline. | This scale includes 21 symptom-questions to assess the emotional-mental state (questions 1-11), somatic manifestations (questions 12 to 18), vasomotor status (questions 19 and 20) and sexual status (21 questions). There are 4 answer options for each question, as in the assessment of the Kupperman index: symptoms do not bother at all - 0 points, slightly bother - 1 point, bother quite strongly - 2 points, extremely pronounced - 3 points. Indicators characteristic of the presence of anxiety or depression - 10 points or more, scored in the first 11 questions. The presence of somatic disorders - 6 or more points in 12-18 questions. Violation of vasomotor function - 4 or more points in 19 and 20 questions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Semykina | Contact | +79219565085 | ts@publichealthinstitute.org | |
| Olga Sias | Contact | +7 916 211 8811 | lek@publichealthinstitute.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budget Institution "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" | Recruiting | Moscow | Russia |
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| Duphaston | Drug | Duphaston®, 10 mg |
|
| Klimadynon | Drug | Cimicifuga racemosa rhizomatum extract |
|
| Divigel | Drug | Divigel, 0.1% |
|
| 364 days |
| The frequency of "hot flashes" after 84 days since the initiation of treatment. | 84 days |
| Changes in the intensity of of menopausal symptoms calculated using the Menopause Rating Scale (MRS) after 84, 168, and 364 days since the treatment initiation compared to baseline (Visit 0). | The questionnaire has 11 items and option to check one of 5 degrees of severity of symptoms (from 0 (none) to 5 (very severe) points at the questionnaire). | 84 days, 168 days, 364 days |
| Changes according to the Greene Climacteric Scale in each of the 4 subscales after 84, 168, and 364 days since the initiation of treatment compared to baseline (Visit 0). | This scale includes 21 symptom-questions to assess the emotional-mental state (questions 1-11), somatic manifestations (questions 12 to 18), vasomotor status (questions 19 and 20) and sexual status (21 questions). There are 4 answer options for each question, as in the assessment of the Kupperman index: symptoms do not bother at all - 0 points, slightly bother - 1 point, bother quite strongly - 2 points, extremely pronounced - 3 points. Indicators characteristic of the presence of anxiety or depression - 10 points or more, scored in the first 11 questions. The presence of somatic disorders - 6 or more points in 12-18 questions. Violation of vasomotor function - 4 or more points in 19 and 20 questions. | 84 days, 168 days, 364 days |
| Changes according to the "Hot Flush" Related Daily Interference Scale (HFRDIS) after 84, 168, and 364 days since the initiation of treatment compared to baseline (Visit 0). | The HFRDIS is 10-item scale measuring the degree hot flashes interfere with nine daily activities. | 84 days, 168 days, 364 days |
| The average treatment satisfaction score according to the Likert Scale after 84, 168, and 364 days since the initiation of treatment. | Assessment of satisfaction with treatment is based on the patient's assessment of the degree of his consent or disagreement with the statements in a hierarchical sequence from "completely disagree" through "disagree", "find it difficult to answer", "agree" to "completely agree". | 84 days, 168 days, 364 days |
| Changes in the adipose tissue according to densitometry results after 364 days of treatment compared to baseline (Visit 0). | 364 days |
| Changes in the waist circumference after 364 days of treatment compared to baseline (Visit 0). | 364 days |
| Changes in the bone tissue according to densitometry results after 364 days of treatment compared to baseline (Visit 0). | 364 days |
| Changes in the bone resorption marker β-Cross laps after 364 days of treatment compared to baseline (Visit 0). | 364 days |
| Changes in the bone formation marker (P1NP) after 364 days of treatment compared to baseline (Visit 0). | 364 days |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| C584106 | Klimadynon |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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