The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- HOMA-IR reduction
研究概览
简要总结
This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.
详细描述
There will be 2 groups of treatment; each group will consist of 62 subjects with the treatment regimens :
- Treatment I : 1 capsule of DLBS3233 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
- Treatment II : 1 caplet of Metformin XR 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily) for 6 months of treatment.
Clinical examination to evaluate the efficacy of the investigational drug will be performed at baseline and every interval of 1 month.
Laboratory examinations to evaluate the metabolic efficacy parameters and ultrasonography (USG) examination will be performed at baseline, Month 3rd, and end of study (Month 6th). In addition to that, USG will also be performed about 2 weeks after Month 3rd (Month 3.5th) and after Month 5th (Month 5.5th).
Laboratory examinations to evaluate the reproductive efficacy parameters (reproductive hormone levels) and safety, at baseline and Month 6th (end of study).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female subjects in reproductive age (i.e. 18-40 years)
- •Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the Rotterdam Criteria
- •Subject with insulin resistance defined by: HOMA-IR of > 2.00
排除标准
- •Pregnant and lactating women
- •Subjects known to have Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia
- •Known to have current medical condition, which, is judged by the Investigator could jeopardize subject's health or interfere with the study evaluation, such as diabetes mellitus, uncontrolled hypertension, other cardiovascular diseases, acute or chronic infections, and any known malignancies
- •Impaired renal function (serum creatinine level > 1.5 ULN)
- •Impaired liver function (serum ALT level ≥ 2.5 ULN)
- •Medically-assisted weight loss with medications or surgical procedures
- •Currently having laparoscopic ovarian diathermy (LOD)
- •Currently under treatment with in vitro fertilization (IVF) techniques
- •Have been regularly taking any medications which affect insulin sensitivity as well as reproductive function (i.e. ovulation, menstrual cycle), within ≤ 3 months prior to screening
- •Participating in other clinical trial within 30 days prior to screening
研究组 & 干预措施
Treatment I
1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
干预措施: DLBS3233 (Drug)
Treatment I
1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
干预措施: Placebo caplet of Metformin XR (Drug)
Treatment II
1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)
干预措施: Metformin XR (Drug)
Treatment II
1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)
干预措施: Placebo capsule of DLBS3233 (Drug)
结局指标
主要结局
HOMA-IR reduction
时间窗: 6 months
HOMA-IR reduction from baseline to Month 6th (end of study)
次要结局
- Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio(6 months)
- Fasting insulin level reduction(3 and 6 months)
- Improvement of glucose tolerance(3 and 6 months)
- Reduction of S/A ratio(3 and 6 months)
- Reduction of free testosterone level (calculated)(6 months)
- Change of luteinizing hormone (LH) level(6 months)
- Change of Ferriman-Gallwey Score(3 and 6 months)
- HOMA-IR reduction(3 months)
- Lipid profile improvement(3 and 6 months)
- Liver function(6 months)
- Renal function(6 months)
- Number of adverse events and subjects with events(During 6 months)