CTRI/2021/04/032522已完成3 期
A Phase III, double-blind, randomized, multicenter prospective study to evaluate the efficacy and safety of fixed dose combination of Metformin HCl and Myo-inositol as compared to Metformin in subjects with polycystic ovary syndrome (PCOS).
Eris Lifesciences Ltd13 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2021年7月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 13
- 主要终点
- 1. Percentage of subjects with improvement in Insulin resistance (HOMA-IR) at 24 weeks of treatment in FDC arm vs. Metformin arm.
研究概览
简要总结
A phase III, double-blind, randomized, multicentre, prospective study to evaluate the efficacy and safety of fixed dose combination of metformin HCl + myo-inositol compared to metformin in subjects with Polycystic Ovary Syndrome (PCOS). Total 190 subjects who are fulfilling inclusion criteria will be enrolled in the study.
Screened subjects will be evaluated and the eligible subjects will be enrolled in the study. The subjects will be followed up for week 6, 12, 18 and 24. The subjects lab parameters were evaluated at week 12 and week 24. The primary endpoint assessment will be percentage of subjects with improvement in insulin resistance and menstrual cycle disturbance at week 24. Secondary endpoint assessment will be change in lab parameters after week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Adult female subjects 18 to40 (both inclusive) years of age.
- •2.Subject diagnosed of polycystic ovary syndrome (PCOS), according to Rotterdam Criteria, if she has 2 of the following 3 manifestations: •Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of greater than or equal to 8).
- •â€¢Disturbed ovulatory function with chronic oligomenorrhea (cycles of > 35 days less than nine cycles per year), or amenorrhea (cycle length > 12 weeks) after negative screening pregnancy test.
- •â€¢Polycystic ovary as shown by transvaginal ultrasonography (TVUS).
- •NOTE: As per FIGO recommendation to characterize menstrual irregularities and accordingly, those subjects who are having menstrual cycle of more than 38 days will be included in the study.
- •3.Subjects with established insulin resistance (by using HOMA IR model, which can be supported by clinical evidences of BMI more than 23 or impaired GTT or cutaneous manifestations like acanthosisnigricans etc.) 4.Subject is willing and able to take oral medications.
- •5.Subject is willing to continue with regular follow-up as required for the study.
- •6.Subject willing to observe barrier contraception (oral contraceptives or any other hormonal medications not to be consumed) during the study period.
排除标准
- •1.Pregnant or lactating women (urinary pregnancy test will be applied at screening).
- •2.Subject with previous medical history (either laboratory or clinical) or currently having any of the following conditions: Cushings syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumours, uncontrolled thyroid disease, hyperprolactinemia or any other hormonal dysfunction.
- •3.Subject with history or current status of diabetes mellitus, uncontrolled hypertension, symptomatic cardiovascular diseases.
- •4.Subject with any acute or chronic infections at the time of screening.
- •5.Subject with history of malignancies.
- •6.Subject with known history of gynaecological surgery.
- •7.Subject having impaired renal or liver function at the time of screening.
- •8.Subject who is currently on a medically-assisted weight loss program with medication or surgical procedures.
- •9.Subject currently having laparoscopic ovarian diathermy (LOD).
- •10.Subject who is willing to or currently undergoing in vitro fertilization (IVF), or considering participation in any artificial reproduction techniques (ART) program.
- •11.Subject who has received or is currently receiving following medication within past 3months of screening: clomiphene citrate; insulin sensitizers like Metformin and thiazolidinediones; aromatase inhibitors like anastrozole, letrozole; glucocorticoids; gonadotropins; gonadotropin-releasing hormone agonists (GnRHa); hormonal contraceptives; antiandrogens like spironolactone, cyproterone acetate (CPA), and flutamide; anti-obesity drugs; or any traditional or herbal medicines.
- •12.Known history or current use of alcohol, smoker or tobacco user, or Subject with unstable mental illness.
- •13.Subject is participating or has participated in any other clinical trial within last 30 days prior to screening.
- •14.In the opinion of the investigator, the Subject is not eligible to participate or may not complythe study procedures.
结局指标
主要结局
1. Percentage of subjects with improvement in Insulin resistance (HOMA-IR) at 24 weeks of treatment in FDC arm vs. Metformin arm.
时间窗: 24 weeks
2. Percentage of subjects with improvement in menstrual cycle disturbance at 12 and 24 weeks of treatment in FDC arm vs. Metformin arm. (accordance with FIGO recommendations)
时间窗: 24 weeks
次要结局
- Changes in serum testosterone levels after 24 weeks of treatment(Changes in systolic and diastolic blood pressure after 24 weeks of treatment)
研究者
研究点 (13)
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