A phase III controlled clinical trial comparing efficacy of Ovydose® plus Metformin versus Metformin alone in management of Polycystic Ovary Syndrome (PCOS).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Clinical Endpoint
研究概览
简要总结
This study is a randomized, double-blind, parallel Group, multicentric trial comparing the safety and efficacy of Ovydose @ 400mg plus Metformin 1000mg versus Metformin 1000mg alone for 12 months in total of 200 patients (100 patients in each group) with PCOS. The study will be conducted at two centers (SKIMS and JVC). The primary outcome measures will include Clinical endpoints while the Secondary outcome measures will include biochemical and hormonal endpoints which will be recorded at 0 months,4th month, 6th month, 8th month, and 12th month of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •The study will include PCOS women aged 18-45 years who had a confirmed diagnosis of PCOS based on the Rotterdam 2003 criteria.
- •Participants with a body mass index (BMI) ranging from 25 to 30 kg/m² will be included in the study.
- •PCOS Women with no history of type 2 diabetes mellitus, liver or kidney disease, or other severe illnesses will be eligible for participation.
- •The study will exclude PCOS women who were using oral contraceptives or other medications that could impact insulin resistance and/or menstrual irregularities.
排除标准
- •PCOS Women with history of Type 2 DM (diabetes mellitus) will be excluded from the study.
- •Pregnant PCOS women will be excluded from participation in the study
- •PCOS Women with infections, immunological diseases, malignancies, and other hormonal disorders such as deranged PRL (prolactin), TSH (thyroid-stimulating hormone), and 17-OHP (17-hydroxyprogesterone) will be excluded from the study.
- •4.PCOS Women with known cardiac or peripheral vascular diseases will be excluded from the study.
- •5.PCOS Women who were on insulin therapy will be exempted from participation in the study.
- •PCOS Women with impaired hepatic or renal function will be excluded from the study.
- •Those PCOS women who were taking ginseng or other herbs for diabetes will be excluded from the study.
- •Participants who were already involved in any other investigational drug studies will be excluded from the study.
结局指标
主要结局
Clinical Endpoint
时间窗: 0 month | Fourth month | Sixth month | Eighth month | Twelfth month
1.Menstrual irregularities
时间窗: 0 month | Fourth month | Sixth month | Eighth month | Twelfth month
4.Hirsutism (FG score)
时间窗: 0 month | Fourth month | Sixth month | Eighth month | Twelfth month
2.No of cycles per year
时间窗: 0 month | Fourth month | Sixth month | Eighth month | Twelfth month
3.Blood Pressure.
时间窗: 0 month | Fourth month | Sixth month | Eighth month | Twelfth month
5.Acne will be evaluated using a standardized scoring system.
时间窗: 0 month | Fourth month | Sixth month | Eighth month | Twelfth month
次要结局
- Hormonal Endpoint(1.The levels of SHBG, LH, FSH, testosterone, estradiol, & prolactin will be measured at baseline and at 12 months.)