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

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.

Conditions

• Endometriosis

Interventions

DIETARY_SUPPLEMENT

D-Chiro-Inositol

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

OTHER

Placebo

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

Sponsors & Collaborators

• University of Palermo

  lead OTHER

Principal Investigators

• Antonio Simone Laganà, M.D., Ph.D. · University of Palermo

• Pietro Serra, M.D. · University of Palermo

• Giuseppe Mascellino, M.D. · University of Palermo

• Andrea Etrusco, M.D. · University of Palermo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2025-02-15

Completion

2025-03-15

Countries

• Italy

Study Locations