protocolSection identificationModule nctId: NCT06314126, orgStudyIdInfo id: ENDO-DCI, briefTitle: Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis, acronym: ENDO-DCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized placebo-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: D-Chiro-Inositol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Estradiol, secondaryOutcomes measure: Pelvic pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: "Paolo Giaccone" Hospital, status: RECRUITING, city: Palermo, zip: 90127, country: Italy, contacts name: Antonio Simone Laganà, M.D., Ph.D., role: CONTACT, contacts name: Pietro Serra, M.D., role: SUB_INVESTIGATOR, contacts name: Giuseppe Mascellino, M.D., role: SUB_INVESTIGATOR, contacts name: Andrea Etrusco, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False