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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use Metformin for 3 months to treat PCOS | Experimental | 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 |
|
| Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Use Metformin for 3 months to treat PCOS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sex hormone binding globulin (SHBG) | Changes in sex hormone binding globulin (SHBG) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in free testosterone (FT) | Changes in free testosterone (FT) | 12 weeks |
| Changes in Luteinizing Hormone (LH) | Changes in Luteinizing Hormone (LH) |
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Inclusion Criteria:
Exclusion Criteria:
type 1 or type 2 diabetes mellitus
Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Serious systemic disease or malignant tumor
History of pancreatitis (chronic, acute or recurrent)
Body weight change ≥10% at 3 months before treatment
Used oral contraceptives or sex hormone drugs in the past 1 month
Used oral glucocorticoids in the past 1 month
Substance (alcohol or drug) abuse or dependence within 3 months
Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2)
Increase of transaminases up to < 2.5 times of upper limit of normal value
Have a history of thromboembolic disease or thrombotic tendency
Subjects in pregnant or lactating or within 1 year after delivery
Subjects have an allergic history to the drugs used in the study
Subjects have participated in other clinical researches of medicine within
1 month prior to randomization
Use of metformin, pioglitazone, or pioglitazone combined with metformin within 30 days before screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 |
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| Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets |
| Drug |
Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS |
|
| 12 weeks |
| Changes in follicle stimulating hormone (FSH) | Changes in follicle stimulating hormone (FSH) | 12 weeks |
| Changes in total testosterone (TT) | Changes in total testosterone (TT) | 12 weeks |
| Changes in dehydroepiandrosterone sulfate (DHEAS) | Changes in dehydroepiandrosterone sulfate (DHEAS) | 12 weeks |
| Changes in anti-müllerian hormone (AMH) | Changes in anti-müllerian hormone (AMH) | 12 weeks |
| Changes in progesterone (Prog) | Changes in progesterone (Prog) | 12 weeks |
| Changes in prolactin (PRL) | Changes in prolactin (PRL) | 12 weeks |
| Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) | glucose obtained at 0 minutes during the OGTT. | 12 weeks |
| Changes in frequency of menstrual cycle | Changes in frequency of menstrual cycle | 12 weeks |
| Change in Acne severity score | Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome. | 12 weeks |
| Change in Ferriman-Gallwey score | Change in Ferriman-Gallwey score#the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome. | 12 weeks |
| Change in waist circumference(WC) | Change in waist circumference(WC) | 12 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |