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Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis - Trial NCT06314126

Access comprehensive clinical trial information for NCT06314126 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Palermo and is currently Recruiting. The study focuses on Endometriosis. Target enrollment is 32 participants.

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NCT06314126
Recruiting
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06314126
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Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis

Study Focus

Endometriosis

D-Chiro-Inositol

Interventional

dietary supplement

Sponsor & Location

University of Palermo

Palermo, Italy

Timeline & Enrollment

N/A

Jan 01, 2024

Apr 01, 2025

32 participants

Primary Outcome

Estradiol

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.

ICD-10 Classifications

Endometriosis
Other endometriosis
Endometriosis, unspecified
Endometriosis of uterus
Endometriosis of ovary

Data Source

ClinicalTrials.gov

NCT06314126

Non-Device Trial