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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-Chiro-Inositol | Experimental | Patients will receive oral D-Chiro-Inositol. |
|
| Placebo | Placebo Comparator | Patients will receive oral placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Chiro-Inositol | Dietary Supplement | Patients in the experimental group will receive 1200 mg of oral D-Chiro-Inositol per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Simone Laganà , M.D., Ph.D. | University of Palermo | Principal Investigator |
| Pietro Serra, M.D. | University of Palermo | Study Chair |
| Giuseppe Mascellino, M.D. | University of Palermo | Study Chair |
| Andrea Etrusco, M.D. | University of Palermo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Paolo Giaccone" Hospital | Palermo | 90127 | Italy |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Randomized placebo-controlled trial
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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.
| Placebo | Other | Patients in the control group will receive 1200 mg of placebo per day. |
|
| D000091662 | Genital Diseases |