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临床试验/NCT06314126
NCT06314126已完成不适用

Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis

University of Palermo2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Estradiol

研究概览

简要总结

To date, the treatment for endometriosis is represented by the surgical removal of the lesions. Nonetheless, in the years following surgery, the lesions can recur, often due to excessive estrogen production. To balance estrogen, progestin- or estrogen-progestin-based medications are generally prescribed. On the other hand, progestins and estrogen-progestins act as contraceptives, preventing the onset of a pregnancy. At the same time, these can have side effects that can affect up to 30% of patients. For these and other reasons, some women refuse therapy with progestins or estrogen-progestins, preferring to resort to no treatment.

Considering the need to research effective molecules in the prevention of relapses that can maintain fertility and avoid unwanted effects, the research focuses on natural molecules, well tolerated by the body.

D-Chiro-Inositol (DCI) is a polyol normally present in human cell membranes, where, from a metabolic point of view, it acts as a second messenger of insulin, while from a hormonal point of view, it exerts an on the biosynthesis of androgens. This effect on steroidogenesis can be attributed to more than one mechanism. In the ovary, DCI stimulates direct testosterone production. Furthermore, it stimulates the accumulation of testosterone by reducing the activity of the aromatase enzyme, responsible for the conversion of androgens into estrogens. Considering the responsiveness of endometriosis to estrogens, and that these constitute a risk factor for recurrences following surgical removal, the use of DCI could be interesting from a clinical point of view.

The study plans to verify whether D-Chiro-Inositol dietary supplementation can be effective in reducing systemic estrogen levels in women with endometriosis, thus also reducing the risk of relapses and associated symptoms.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Participants and investigators will be masked to the treatment allocation. Treatment pills and placebo pills will be the same in shape, taste, color, and size.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women affected by endometriosis (regardless of the stage)

排除标准

  • Treatment with hormones in the previous three months or during the study
  • Treatment with Inositol and/or other insulin-sensitizers in the previous three months
  • Cancer (any site/stage)

研究组 & 干预措施

Placebo

Placebo Comparator

Patients will receive oral placebo.

干预措施: Placebo (Other)

结局指标

主要结局

Estradiol

时间窗: At the 3° day of the menstrual cycle before to start the study, after one month, after three months, after six months from the enrollment

Serum estradiol level by peripheral blood test

次要结局

  • Pelvic pain(At the 3° day of the menstrual cycle before to start the study, after one month, after three months, after six months from the enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Simone Laganà

Principal Investigator

University of Palermo

研究点 (2)

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