Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314126
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDO-DCI
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None