Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03142633 - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed NCT06158932 - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04932070 - Berberine and Polycystic Ovary Syndrome N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03480022 - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS Phase 3
Active, not recruiting NCT03043924 - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed NCT05981742 - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS Phase 2
Completed NCT05702957 - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome Phase 2/Phase 3
Completed NCT05029492 - Effect of Visceral Manipulation on PCOS N/A
Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Not yet recruiting NCT02255578 - Endobarrier Treatment in Women With PCOS Phase 3
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A