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临床试验/NCT06715527
NCT06715527已完成不适用

Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome

Lo.Li.Pharma s.r.l2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Restoration of regular menstrual cycle

研究概览

简要总结

In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.

Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.

In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PCOS according to the Rotterdam Criteria
  • Clinical or biochemical hyperandrogenism

排除标准

  • other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
  • other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
  • use of medications that influence ovulation
  • hormonal treatments
  • chronic pharmacological therapies
  • use of inositol-containing supplements
  • regular consumption of inositol-enriched food

结局指标

主要结局

Restoration of regular menstrual cycle

时间窗: From enrollment (T0) to the completion of the study at 3 months (T3M)

Number (%) of patients with regular menstrual cycle at the end of the study

次要结局

  • Hormonal status(From enrollment (T0) to the completion of the study at 3 months (T3M))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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