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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06125587
Other study ID # 2023PS581K
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date November 2023
Est. completion date May 2026

Study information

Verified date November 2023
Source Shengjing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, we applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date May 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Female aged 18- 45 years old 2. Normal weight BMI 18.5--24 3. Diagnosis of hyperandrogenism T>0.481ng/ml 4. The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus 5. No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit Exclusion Criteria: 1. T level is within the normal range 2. Organ dysfunction 3. Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months 4. Confirmed diagnosis of diabetes 5. Are on a diet, use weight-affecting medications, or have experienced a weight change of >4.5kg within 3 months prior to the start of the study 6. Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc. 7. Combined psychiatric disorders and severe primary diseases 8. Allergy to the drug or components of this study 9. Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chiglitazar
Chiglitazar is a novel PPAR agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARa, PPAR? and PPARd, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization.
Metformin
Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.

Locations

Country Name City State
China Shengjing Hospital of China Medical University Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma insulin level Changes in insulin level before and after treatment Three months
Secondary Total testosterone Changes in total testosterone (TT) Three months
Secondary Sex hormone-binding globulin Changes in sex hormone-binding globulin (SHBG) Three months
Secondary Ratio of luteinizing hormone to follicular estrogen Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH) Three months
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