Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 7
- 主要终点
- HOMA-IR reduction
研究概览
简要总结
This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.
详细描述
There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following:
- Treatment I : DLBS3233 100 mg once daily
- Treatment II : Metformin XR 750 mg twice daily
- Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily.
Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th).
Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study.
Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct.
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
- •Signed written informed consent prior to participation in the study.
- •Female subjects in reproductive age (i.e. 18-40 years) willing to conceive.
- •Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the following (Rotterdam Criteria):
- •Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of ≥ 8).
- •Ovarian dysfunction indicated by menstrual irregularity: oligomenorrhea (cycles of > 35 days), or amenorrhea (no menses in the last of 3 months) after negative screening pregnancy test.
- •Polycystic ovary as shown by ultrasonography (USG).
- •Subject with insulin resistance defined by : HOMA-IR of > 2.
- •Subject with body mass index (BMI) of 19-35 inclusive.
- •Able to take oral medication.
排除标准
- •Pregnant or lactating women (urinary pregnancy test will be applied at screening).
- •Based on previous or current medical (either laboratory or clinical) examination, subjects known to have any of the following conditions:
- •Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia.
- •Known to have the following medical condition:
- •Diabetes mellitus,
- •Uncontrolled hypertension
- •Symptomatic cardiovascular diseases:
- •Acute or chronic infections at baseline.
- •Any known malignancies.
- •History of gynecological surgery.
- •Impaired renal function
- •Impaired liver function
- •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 of the following medications, within ≤ 3 months prior to screening, such as:
- •Clomiphene citrate
- •Insulin sensitizers, i.e. metformin and thiazolidinediones
- •Aromatase inhibitors, such as: anastrozole, letrozole
- •Glucocorticoids
- •Gonadotropins
- •Gonadotropin-releasing hormone agonists (GnRHa)
- •Oral contraceptive pills (OCPs)
- •Antiandrogens, such as: spironolactone, cyproterone acetate (CPA), and flutamide
- •Any traditional or herbal medicines
- •Participating in other clinical trial within 30 days prior to screening.
研究组 & 干预措施
Treatment I : DLBS3233
DLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months
干预措施: DLBS3233 (Drug)
Treatment I : DLBS3233
DLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months
干预措施: Placebo metformin (Drug)
Treatment II : Metformin
Metformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months
干预措施: Metformin XR (Drug)
Treatment II : Metformin
Metformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months
干预措施: Placebo DLBS3233 (Drug)
Treatment III : Combination DLBS3233 and Metformin
DLBS3233 100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily; orally, for 6 months.
干预措施: DLBS3233 (Drug)
Treatment III : Combination DLBS3233 and Metformin
DLBS3233 100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily; orally, for 6 months.
干预措施: Metformin XR (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 waist circumference(1, 2, 3, 4, 5, and 6 months)
- Renal function(6 months)
- Lipid profile improvement(3 and 6 months)
- Improvement of glucose tolerance(3 and 6 months)
- Response rate: presence of ovulation(menstrual cycle of Month 3rd up to that of Month 6th)
- Change of endometrium thickness(3 to 6 months)
- Reduction of free testosterone level(6 months)
- Change of luteinizing hormone (LH) level(6 months)
- Improvement of S/A ratio(3 to 6 months)
- Improvement in Ferriman-Gallwey Score(3 and 6 months)
- Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio(6 months)
- Liver function(6 months)
- Number of adverse events and subjects with events(During 6 months)