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

NCT06314126 | Completed DMC

• 1 other identifier: ENDO-DCI
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

D-Chiro-Inositol; Endometriosis

Outcome Measures

Primary Outcomes (1)

• Estradiol

  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 Outcomes (1)

• 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

Study Arms (2)

D-Chiro-Inositol

EXPERIMENTAL

Patients will receive oral D-Chiro-Inositol.

Dietary Supplement: D-Chiro-Inositol

Placebo

PLACEBO COMPARATOR

Patients will receive oral placebo.

Other: Placebo

Interventions

D-Chiro-Inositol DIETARY_SUPPLEMENT

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

D-Chiro-Inositol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women affected by endometriosis (regardless of the stage)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

"Paolo Giaccone" Hospital

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  University of Palermo

  PRINCIPAL INVESTIGATOR

• Pietro Serra, M.D.

  University of Palermo

  STUDY CHAIR

• Giuseppe Mascellino, M.D.

  University of Palermo

  STUDY CHAIR

• Andrea Etrusco, M.D.

  University of Palermo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: April 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)