Effects of Pioglitazone Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients With Hyperandrogenemia.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in sex hormone binding globulin (SHBG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Use Metformin for 3 months to treat PCOS
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
干预措施: Metformin (Drug)
Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS
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
干预措施: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets (Drug)
结局指标
主要结局
Changes in sex hormone binding globulin (SHBG)
时间窗: 12 weeks
Changes in sex hormone binding globulin (SHBG)
次要结局
- Changes in frequency of menstrual cycle(12 weeks)
- Changes in follicle stimulating hormone (FSH)(12 weeks)
- Change in Acne severity score(12 weeks)
- Change in waist circumference(WC)(12 weeks)
- Changes in Luteinizing Hormone (LH)(12 weeks)
- Changes in prolactin (PRL)(12 weeks)
- Changes in free testosterone (FT)(12 weeks)
- Changes in total testosterone (TT)(12 weeks)
- Changes in anti-müllerian hormone (AMH)(12 weeks)
- Changes in dehydroepiandrosterone sulfate (DHEAS)(12 weeks)
- Changes in progesterone (Prog)(12 weeks)
- Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)(12 weeks)
- Change in Ferriman-Gallwey score(12 weeks)
研究者
Bing He
Professor
Shengjing Hospital