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

Endometriosis Clinical Trial

— ENDO-DCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314126
• Other study ID #: ENDO-DCI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: University of Palermo
• Contact: Antonio Simone Laganà, M.D., Ph.D.
• Phone: +39 3296279579
• Email: antoniosimone.lagana[@]unipa.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Italy	"Paolo Giaccone" Hospital	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pelvic pain	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