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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2025-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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D-Chiro-Inositol

Patients will receive oral D-Chiro-Inositol.

Group Type EXPERIMENTAL

D-Chiro-Inositol

Intervention Type DIETARY_SUPPLEMENT

Patients in the experimental group will receive 1200 mg of oral D-Chiro-Inositol per day.

Placebo

Patients will receive oral placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients in the control group will receive 1200 mg of placebo per day.

Interventions

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D-Chiro-Inositol

Patients in the experimental group will receive 1200 mg of oral D-Chiro-Inositol per day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Patients in the control group will receive 1200 mg of placebo per day.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No