polycystic ovary syndrome
Conditions
Interventions
Subgroup 1 of clinical evaluation group (Abnormal reproductive phenotype):Diane-35 (PO QD)(After fifth days of menstruation, it will be used for 21 days, and the drug will be stopped for 7 days)
Subgroup 2 of clinical evaluation group (Abnormal metabolic phenotype):Metformin (PO 1000-2000mg/d)
Subgroup 1 of metabonomics evaluation group (Abnormal hormone metabolism):Diane-35 (PO QD)(After fifth days of menstruation, it will be used for 21 days, and the drug will be stopped for 7 days)
Subgroup 2 of metabonomics evaluation group (Abnormal lipid metabolism):Metformin (PO 1000-2000mg/d)
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy subjects 1. Can understand and voluntarily sign informed consent; 2. Women of childbearing age at the age of 18-45; 3. Menstrual history is normal. Inclusion criteria for PCOS subjects 1.Can understand and voluntarily sign informed consent; 2.Women of childbearing age at the age of 18-45; 3.The clinical diagnosis is PCOS.
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy subjects 1. A history of infertility and PCOS; 2. A history of insulin resistance, obesity, diabetes, metabolic syndrome, adverse events during pregnancy, or hepatitis B, hepatitis C, syphilis, AIDS; 3. Is or has received the treatment of estrogen, progesterone, lipid-lowering and hypoglycemic drugs; 4. Antibiotics, microbial regulators and other drugs were taken within the first 12 weeks of the first screening phase; 5. A history of malignancy, especially gynecologic malignancies and history of radiotherapy and chemotherapy; 6. A family history of PCOS and a history of father's alopecia; 7. Pregnant or lactating women; 8. Patients with congenital adrenal hyperplasia / hypercortisolism / secretory androgenic tumor / Cushing syndrome / thyroid dysfunction / hypo hydanotropin / hyperprolactinemia disease / premature ovarian insufficiency / functional hypothalamic amenorrhea; 9. It may not be possible to complete all research visits or procedures required by all research projects and / or fail to comply with all required research procedures; 10. There are any other clinical history or evidence of the disease (except the above listed), and will cause risk or interference to the subject's safety assessment, procedure, or completion. Exclusion criteria for PCOS subjects 1. Currently being treated in another experimental device or drug research, or the end of another experimental instrument or drug treatment is less than 30 days; 2. Diane-35,metformin,or other estrogen and progesterone, lipid regulating, and hypoglycemic drugs were received within the first 12 weeks of the first screening stage (allowing for the use of liver protection drugs); 3. Known to be allergic or intolerant to the Diane-35, metformin or any of the ingredients used; 4. Take glucocorticoids, spironolactone and anti inflammatory drugs within the first 12 weeks of the first screening phase; 5. Take antibiotics, microbial regulators and other drugs within the first 12 weeks of the first screening phase; 6. Patients with congenital adrenocortical hyperplasia / polycythemia / secretory androgenic tumor / Cushing syndrome / thyroid dysfunction / hypothyroidism / hyperprolactinemia / premature ovarian insufficiency / functional hypothalamus / diabetes; 7. A history of malignancy, especially gynecologic malignancies and history of radiotherapy and chemotherapy; 8. Liver function impairment (ALT, AST > 1.5 times in laboratory population), chronic liver disease; 9. With whole blood cell reduction / thrombotic disease; 10. Pregnant or projected, planned to be pregnant during this study period or unwilling to contraception; 11. According to medical history, physical examination and routine laboratory examination, the subject had unstable medical conditions, or the researchers felt unstable for other reasons; 12. The use of grapefruit juice during the study period; 13. A history of ventricular tachycardia with torsional ventricular tachycardia; 14. It may not be possible to complete all research visits or procedures required by all research projects and / or fail to comply with all required research procedures; 15. There are any other clinical history or evidence of the disease (except the above listed), and will cause risk or interference to the subject's safety assessment, procedure, or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| B-ultrasound;Metabonomics;Sex hormone related indicators;Blood lipid related indexes;Endocrine related indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical measurement;Physical examination; | — |
Countries
China
Contacts
Public ContactXu Lan
Wuxi People's Hospital
Outcome results
None listed