Evaluation of the Efficacy of the Combination of Antioxidants Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With Polycystic Ovary Syndrome: A Prospective Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Mean BMI at 6 Months
研究概览
简要总结
Evaluate the efficacy of the combination of antioxidants ALA, NAC, Vit. B6 and SAMe as a dietary supplement, in the improvement of metabolic and endocrine parameters and clinical manifestations of PCOS.
详细描述
The investigators will explain the study to all patients who meet the inclusion and exclusion criteria during the study period. After signing the informed consent patients will be randomized 1:1 to oral contraceptive 4 mg drospirenone once daily or oral contraceptive 4 mg drospirenone + combination of 200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg Alpha lipoid acid and 0,65 mg vitamin B6 (Metionac) twice daily. Patients for whom oral contraceptive is not indicated will be enrolled in third study group of Metionac twice daily. 2 study visits will be carried out, Baseline (Visit 0) and after 6 months therapy (Visit 1).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women newly diagnosed with PCOS with at least 2 of the following symptoms:
- •Oligo/Anovulation < 21 or > 35 days > 90 days (any cycle) < 8 periods / year
- •Hyperandrogenism (clinical symptoms or laboratory results)
- •Polycystic ovary morphology (NHMRC guideline): In any ovary:
- •20 follicles* and/or ovarian volume greater than or equal to 10ml and no corpus luteum, cysts or dominant follicles
- •*number of follicles per ovary measuring 2-9 mm
- •> 18 years old
- •Overweight defined as BMI>25
- •Normal prolactin levels
- •Women with altered coagulation factors or a personal history of thromboembolism for whom OAC is contraindicated (they will be included in the control group without randomization)
- •Written inform consent
排除标准
- •Diabetic women
- •Adrenal enzyme deficiency and/or other endocrine disease
- •Pregnant or lactating women.
- •Women under treatment with SNRIs (serotonin reuptake inhibitors)
- •Other serious illness
研究组 & 干预措施
Oral Contraceptive
Drospirenone 4 mg once a day for 6 months
干预措施: Oral contraceptive (Drug)
Oral Contraceptive + Food supplement Metionac
Drospirenone 4 mg once a day and Metionac twice daily (200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 Vitamin B6) for 6 months
干预措施: Metionac (Dietary Supplement)
Oral Contraceptive + Food supplement Metionac
Drospirenone 4 mg once a day and Metionac twice daily (200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 Vitamin B6) for 6 months
干预措施: Oral contraceptive (Drug)
Food supplement MetioNac
Metionac twice daily (200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 Vitamin B6) for 6 months
干预措施: Metionac (Dietary Supplement)
结局指标
主要结局
Change from Baseline in the Mean BMI at 6 Months
时间窗: 6 months
Evolution of Body Mass Index in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Insuline level at 6 Months
时间窗: 6 months
Evolution of Insuline level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Glucose level at 6 Months
时间窗: 6 months
Evolution of Glucose level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Triglycerides at 6 Months
时间窗: 6 months
Evolution of Triglycerides level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean HDL at 6 Months
时间窗: 6 months
Evolution of high-density lipoprotein (HDL) cholesterol level in patients with PCOS after 6 months therapy.
Change from Baseline in the Mean LDL at 6 Months
时间窗: 6 monhts
Evolution of low-density lipoprotein (LDL) level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean AST at 6 months
时间窗: 6 months
Evolution of aspartate aminotransferase (AST) level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean ALT at 6 months
时间窗: 6 months
Evolution of alanine aminotransferase (ALT) level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean GGT at 6 months
时间窗: 6 months
Evolution of gamma glutamyltransferase (GGT) level in patients with PCOS after 6 months therapy
Change from Baseline in the Mean Bilirubin at 6 Months
时间窗: 6 months
Evolution of total and free bilirubin level in patients with PCOS after 6 months therapy
次要结局
- Change from Baseline in the Mean 17 beta estradiol at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months(6 months)
- Change from Baseline in the Mean 17 hydroxy progesterone at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months(6 months)
- Change from Baseline in the Mean LH at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months(6 months)
- Change from Baseline in the Mean FSH at 6 months Translate from: English volume_up 20 / 5,000 Translation results Change from baseline in the Mean 17 beta estradiol at 6 Months(6 months)
- Change from Baseline in the Mean Testosterone at 6 months(6 months)
- Change from Baseline in the Mean Androstenedione at 6 months(6 months)
- Change from Baseline in the Mean DHEA at 6 months(6 months)
- Change from Baseline in the Mean TSH at 6 months(6 months)
- Change from Baseline in the Mean Homocysteine at 6 months(6 months)
- Change from Baseline in the Mean HOMA-IR at 6 months(6 months)
- Change from Baseline in the Mean Hb A1c at 6 months(6 months)
- Change from Baseline in the Mean SHBG at 6 months(6 months)
- Change from Baseline in the Mean Hirsutism score at 6 months(6 months)
- Change from Baseline in the Mean Acne self-assessment score at 6 months(6 months)
- Change from Baseline in the Mean Alopecia score at 6 months(6 months)
- Change from Baseline in the Proportion of patients with irregular menstrual cycle at 6 months(6 months)
- Change from Baseline in the Mean Migraine score at 6 months(6 months)
- Change from Baseline in the Mean QoL score at 6 months(6 months)