Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Serum Anti-Müllerian hormone (AMH)
研究概览
简要总结
The goal of this interventional Randomized clinical is to compare the effect of Metformin alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi female patients with polycystic ovary syndrome. The main questions to answer are:
- What are the effects of the tested regimens on Body mass index (BMI)?
- What are the effects of the tested regimens on hormonal status?
- What are the effects of the tested regimens on uterine artery resistive index ?
- What are the effects of the tested regimens on some inflammatory markers?
Participants will be separated into two groups:
- Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
- Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
- Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).
Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.
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
- •Age 18 - 40 years
- •Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria
- •Body Mass Index (BMI) < 40 Kg/m²
排除标准
- •Age less than 18 years or more than 40 years
- •Co-morbid conditions including (diabetes mellitus, essential hypertension, and thyroid disease)
- •Patients planning for conception.
- •Body Mass Index > 40 Kg/m²
研究组 & 干预措施
Group 1 (M)
25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.
干预措施: Metformin Hydrochloride 500 MG (Drug)
Group 2 (D)
25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.
干预措施: Cabergoline 0.5 MG (Drug)
Group 3 (MD)
25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily and Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.
干预措施: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG (Drug)
结局指标
主要结局
Serum Anti-Müllerian hormone (AMH)
时间窗: at Baseline, and after 90 days
Measured in ng/mL as a part of hormone status changes analysis
Mean number of dominant follicles (DF)
时间窗: at Baseline, and after 90 days
Calculated by ultrasonography as a part of the ultrasonic analysis
Serum Anti-GAD antibody
时间窗: at Baseline, and after 90 days
Measured in ng/mL as a part of inflammatory markers analysis
Mean Resistive Index (RI)
时间窗: at Baseline, and after 90 days
Calculated by ultrasonography as a part of the ultrasonic analysis
Serum Testosterone
时间窗: at Baseline, and after 90 days
Measured in ng/mL as a part of hormone status changes analysis
Serum Follicular Stimulating Hormone (FSH)
时间窗: at Baseline, and after 90 days
Measured in mIU/mL as a part of hormone status changes analysis
Serum Prolactin (PRL)
时间窗: at Baseline, and after 90 days
Measured in ng/mL as a part of hormone status changes analysis
Serum Anti-GnRH antibody
时间窗: at Baseline, and after 90 days
Measured in pg/mL as a part of inflammatory markers analysis
Body Mass Index (BMI)
时间窗: at Baseline, and after 90 days
Measured in Kg/m² as a part of hormone status changes analysis
Serum Luteinizing hormone (LH)
时间窗: at Baseline, and after 90 days
Measured in mIU/mL as a part of hormone status changes analysis
Serum IL-18 Level
时间窗: at Baseline, and after 90 days
Measured in pg/mL as a part of inflammatory markers analysis
次要结局
未报告次要终点
研究者
Hayder Adnan Fawzi
Associate Professor
Al-Rasheed University College