Clinical trial NCT06314126: Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis
Official title: Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: D-Chiro-Inositol
Endometriosis
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Estradiol
timeFrame: 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:
measure: Pelvic pain
timeFrame: 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
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: "Paolo Giaccone" Hospital
Study officials:
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Palermo
name: Pietro Serra, M.D.
role: STUDY_CHAIR
affiliation: University of Palermo
name: Giuseppe Mascellino, M.D.
role: STUDY_CHAIR
affiliation: University of Palermo
name: Andrea Etrusco, M.D.
role: STUDY_CHAIR
References: