Clinical trial · Interventional
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
NCT04969627CI-TRIAL-00057823completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exenatide | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Metformin (BMI<24)
- description
- Subjects: PCOS patients whoseBMI\<24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months
- interventionNames
- Drug: Metformin
- type
- EXPERIMENTAL
- label
- Metformin (BMI≥24)
- description
- Subjects: PCOS patients whoseBMI≥24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months
- interventionNames
- Drug: Metformin
- type
- EXPERIMENTAL
- label
- Combination (BMI<24)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria 2. Overweight/obesity (BMI≥24 kg/m2) 3. No pregnant plan in recent 6 months 4. Written consent for participation in the study Exclusion Criteria: 1. type 1 or type 2 diabetes mellitus 2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia 3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 4. Serious systemic disease or malignant tumor 5. History of pancreatitis (chronic, acute or recurrent) 6. Body weight change ≥10% at 3 months before treatment 7. Used oral contraceptives or sex hormone drugs in the past 1 month 8. Used oral glucocorticoids in the past 1 month 9. Substance (alcohol or drug) abuse or dependence within 3 months 10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d) 11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR\<60ml/min/1.73m2) 12. Increase of transaminases up to \< 2.5 times of upper limit of normal value 13. Have a history of thromboembolic disease or thrombotic tendency 14. Subjects in pregnant or lactating or within 1 year after delivery 15. Subjects have an allergic history to the drugs used in the study 16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization 17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening
References
Publications (0)
Data not yet available
No reference posted for this study.