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OpenTrials
Completed

NCT Number: NCT06314126

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

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

"Paolo Giaccone" Hospital

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

D-chiro-inositol

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Acronym: ENDO-DCI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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