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Clinical study of insulin resistance and hormonal improvement by chiglitazar in polycystic ovary syndrome

Clinical study of insulin resistance and hormonal improvement by chiglitazar in polycystic ovary syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096097
Enrollment
Unknown
Registered
2025-01-17
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome (PCOS)

Interventions

chiglitazar:chiglitazar 48mg qd
metformin:metformin 1.5g qd

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? Age 18-40 years old; ?BMI of 24.0-38.0 kg/m^2; No other serious chronic diseases; Liver function, renal function, HIV/HCV and electrocardiogram were normal. The diagnostic criteria for polycystic ovary syndrome were met, and other diseases such as congenital adrenal hyperplasia, Cushing's syndrome and androgen secreting tumors were excluded. (Ref: Chinese expert consensus on total polycystic ovary syndrome, Chinese Journal of Endocrinology and Metabolism,2018,34(1) : 1-5); ? After fully understanding the content of the experiment, volunteer to be tested and sign the informed consent.

Exclusion criteria

Exclusion criteria: Diabetes mellitus (type 1 or type 2) was diagnosed before inclusion; ? Chronic heart, liver and kidney disease; Have drug allergy, allergic disease history or allergic constitution; Smokers and alcoholics; ? Combined with Cushing's syndrome, congenital adrenal hyperplasia, benign and malignant tumors of various systems, abnormal liver and kidney function, organic heart disease, rheumatoid arthritis, systemic lupus erythematosus, polycystic kidney, psychiatric diseases, HIV/ tuberculosis /HCV and other chronic diseases; ? History of using glucocorticoids, estrogens, progesterone and insulin within 3 months before inclusion; ? Patients who cannot cooperate with follow-up due to personal reasons; Also include: 1) patients who are participating in another clinical trial within one month before the trial; 2) Researchers consider other reasons not appropriate for clinical trial participants.

Design outcomes

Primary

MeasureTime frame
testosterone;estradiol;Anti-mullerian hormone;Follicle-stimulating hormone;luteinizing hormone;

Secondary

MeasureTime frame
Glycosylated hemoglobin;triglyceride;cholesterol;low density lipoprotein cholesterin;high density lipoprotein cholesterol;weight;height;

Countries

china

Contacts

Public ContactDongfang Liu

The Second Affiliated Hospital of Chongqing Medical University

ldf023023@qq.com+86 186 2340 7751

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026