Endometriosis
Conditions
Keywords
D-Chiro-Inositol, Endometriosis
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.
Interventions
DIETARY_SUPPLEMENTD-Chiro-Inositol
Patients in the experimental group will receive 1200 mg of oral D-Chiro-Inositol per day.
OTHERPlacebo
Patients in the control group will receive 1200 mg of placebo per day.
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
Randomized placebo-controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estradiol | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic 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 | Pelvic pain measured as visual analog scale (VAS), from 0 (no pain) to 10 (maximal perceived pain). |
Countries
Italy
Outcome results
None listed