Status:
COMPLETED
Chiglitazar/Metformin in Non-obese Women With PCOS
Lead Sponsor:
Shengjing Hospital
Conditions:
Polycystic Ovary Syndrome
Chiglitazar
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Female aged 18- 45 years old
- Normal weight BMI 18.5--24
- Diagnosis of hyperandrogenism T\>0.481ng/ml
- The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus
- No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit
Exclusion
- T level is within the normal range
- Organ dysfunction
- Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months
- Confirmed diagnosis of diabetes
- 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
- Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc.
- Combined psychiatric disorders and severe primary diseases
- Allergy to the drug or components of this study
- Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06125587
Start Date
November 15 2023
End Date
November 20 2024
Last Update
January 1 2025
Active Locations (1)
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1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110000