Effects of Pioglitazone Combined With Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients.
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT05519813
- Lead Sponsor
- Bing He
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
- BMI<24 kg/m2
- No pregnant plan in recent 6 months
- Written consent for participation in the study
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type 1 or type 2 diabetes mellitus
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Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
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Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
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Serious systemic disease or malignant tumor
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History of pancreatitis (chronic, acute or recurrent)
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Body weight change ≥10% at 3 months before treatment
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Used oral contraceptives or sex hormone drugs in the past 1 month
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Used oral glucocorticoids in the past 1 month
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Substance (alcohol or drug) abuse or dependence within 3 months
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Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
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Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2)
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Increase of transaminases up to < 2.5 times of upper limit of normal value
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Have a history of thromboembolic disease or thrombotic tendency
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Subjects in pregnant or lactating or within 1 year after delivery
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Subjects have an allergic history to the drugs used in the study
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Subjects have participated in other clinical researches of medicine within
1 month prior to randomization
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Use of metformin, pioglitazone, or pioglitazone combined with metformin within 30 days before screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets 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 Use Metformin for 3 months to treat PCOS Metformin 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
- Primary Outcome Measures
Name Time Method Changes in sex hormone binding globulin (SHBG) 12 weeks Changes in sex hormone binding globulin (SHBG)
- Secondary Outcome Measures
Name Time Method Changes in frequency of menstrual cycle 12 weeks Changes in frequency of menstrual cycle
Changes in follicle stimulating hormone (FSH) 12 weeks Changes in follicle stimulating hormone (FSH)
Change in Acne severity score 12 weeks Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.
Change in waist circumference(WC) 12 weeks Change in waist circumference(WC)
Changes in Luteinizing Hormone (LH) 12 weeks Changes in Luteinizing Hormone (LH)
Changes in prolactin (PRL) 12 weeks Changes in prolactin (PRL)
Changes in free testosterone (FT) 12 weeks Changes in free testosterone (FT)
Changes in total testosterone (TT) 12 weeks Changes in total testosterone (TT)
Changes in anti-müllerian hormone (AMH) 12 weeks Changes in anti-müllerian hormone (AMH)
Changes in dehydroepiandrosterone sulfate (DHEAS) 12 weeks Changes in dehydroepiandrosterone sulfate (DHEAS)
Changes in progesterone (Prog) 12 weeks Changes in progesterone (Prog)
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) 12 weeks glucose obtained at 0 minutes during the OGTT.
Change in Ferriman-Gallwey score 12 weeks Change in Ferriman-Gallwey score#the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.
Trial Locations
- Locations (1)
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China