Clinical trial · Interventional
Effects of Pioglitazone Combined With Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients.
Effects of Pioglitazone Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients With Hyperandrogenemia.
- 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 pioglitazone combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI \< 24 in China. 60 cases of nonobese PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + ph. To evaluate the improvement of met or met + ph in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients.
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 |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Use Metformin for 3 months to treat PCOS
- description
- Active Comparator: Metformin (BMI\<24) 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
- Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS
- description
- Active Comparator: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets (BMI\<24) Subjects: PCOS patients whoseBMI\<24 Drug: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets Generic name: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets Dosage form: 15mg/500mg Dosage: 2 tablets/day Frequency: one tablet twice a day Duration: 3 months
- interventionNames
- Drug: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets
Primary outcomes (1)
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. 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, pioglitazone, or pioglitazone combined with metformin within 30 days before screeningReferences
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