Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis (ENDO-DCI)

August 1, 2025 updated by: Antonio Simone Laganà, University of Palermo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • "Paolo Giaccone" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-Chiro-Inositol
Patients will receive oral D-Chiro-Inositol.
Dietary supplement: D-Chiro-Inositol
Patients in the experimental group will receive 1200 mg of oral D-Chiro-Inositol per day.
Placebo Comparator: Placebo
Patients will receive oral placebo.
Other: Placebo
Patients in the control group will receive 1200 mg of placebo per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estradiol
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic pain
Time Frame: 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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., University of Palermo
  • Study Chair: Andrea Etrusco, M.D., University of Palermo
  • Study Chair: Pietro Serra, M.D., University of Palermo
  • Study Chair: Giuseppe Mascellino, M.D., University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Actual)

February 15, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-DCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on D-Chiro-Inositol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe