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Patients with AUB will undergo 6-month treatment with D-chiro-inositol and will fill in questionnaires on AUB, with the evaluation of hormonal serum levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients will undergo 3 months treatment with 1200 mg D-chiro-inositol and 120 mg lactalbumin, than 3 months treatment with 600 mg D-chiro-inositol and 60 mg lactalbumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-chiro-inositol and lactalbumin (high dose) | Dietary Supplement | From 0 to 3 months: 1200mg D-chiro-inositol and 120mg lactalbumin per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUB | The "Menstrual Bleeding Questionnaire", a standardized and validated questionnaire, will be administered to patients to evaluate te extent of AUB and the impact on their quality of life. | 0, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of Estradiol | Serum levels of estradiol will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| Serum level of Estrone | Serum levels of estrone will be evaluated after intravenous blood sampling |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007768 | Lactalbumin |
| ID | Term |
|---|---|
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067816 | Whey Proteins |
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| D-chiro-inositol and lactalbumin (low dose) | Dietary Supplement | From 3 to 6 months: 600mg D-chiro-inositol and 60mg lactalbumin per day |
|
| 0, 3 and 6 months |
| Serum level of Testosterone | Serum levels of testosterone will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| Serum level of Androstenedione | Serum levels of androstenedione will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| Serum level of Total cholesterol | Serum levels of total cholesterol will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| Serum level of High-Density Lipoprotein | Serum levels of HDL will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| Serum level of Low-Density Lipoprotein | Serum levels of LDL will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| Serum level of Triglyceride | Serum levels of triglyceride will be evaluated after intravenous blood sampling | 0, 3 and 6 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008894 |
| Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |