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

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Dietary Supplement: D-Chiro-Inositol; Other: Placebo

• Registration Number: NCT06314126
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-15
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-15
• Primary Completion: 2024-11-15
• Study Completion: 2025-03-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Women affected by endometriosis (regardless of the stage)

Exclusion Criteria

• 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
• Obesity
• Diabetes
• Cancer (any site/stage)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-Chiro-Inositol	D-Chiro-Inositol	Patients will receive oral D-Chiro-Inositol.
Placebo	Placebo	Patients will receive oral placebo.

Primary Outcome Measures

Name	Time	Method
Estradiol	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

Secondary Outcome Measures

Name	Time	Method
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	Pelvic pain measured as visual analog scale (VAS), from 0 (no pain) to 10 (maximal perceived pain).

Trial Locations

Locations (1)

"Paolo Giaccone" Hospital; 🇮🇹 Palermo, Italy