"Paolo Giaccone" Hospital
Palermo, 90127, Italy
NCT Number: NCT06314126
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.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Palermo, 90127, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the experimental group will receive 1200 mg of oral D-Chiro-Inositol per day.
Patients in the control group will receive 1200 mg of placebo per day.
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
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).
University of Palermo
Other
Acronym: ENDO-DCI
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.
Published trials that share one or more normalized conditions with this study.
NCT07241637
Endometriosis, Fatigue
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05962034
Endometriosis, Female Urogenital Diseases
University Park, Pennsylvania, United States
View Trial DetailsNCT05019612
Endometriosis, Expectations
Hamburg, Germany
View Trial DetailsNCT00073801
Chronic Pelvic Pain, Endometriosis
Bethesda, Maryland, United States
View Trial Details