PCOS (Polycystic Ovary Syndrome)
Conditions
Keywords
PCOS phenotype D, Diosgenin, Dioscorea
Brief summary
In this study, female patients diagnosed with PCOS of phenotype D will be enrolled. They generally display the following characteristics: menstrual cycle alterations; polycystic ovary morphology at ultrasound; normal blood levels of androgen, particularly testosterone; no signs of clinical hyperandrogenism. Current treatments for this condition include insulin sensitizers (such as metformin) and hormonal contraceptives. However, this specific phenotype of PCOS do not feature metabolic or hormonal alterations, and the efficacy of these treatments has lately been questioned. In the present clinical trial, patients will be given a dietary supplement containing Dioscorea extract (source of Diosgenin, a natural analog of progesterone), vitamin D and alpha-lactalbumin for six month. Restoration of regular menstrual cycle and physiological ultrasound appearance of the ovaries will be the primary goal of the intervention.
Interventions
DIETARY_SUPPLEMENTDiosgenin
Patients will take a tablet containing diosgenin (120 mg), alpha-lactalbumin (100 mg) and vitamin D (50 mcg) - two times per day for six months
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PCOS of phenotype D, according to the Rotterdam Criteria and the EGOI-PCOS Criteria
Exclusion criteria
* Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria and the EGOI-PCOS Criteria * Hormonal treatments; * Treatments with inositol or other insulin sensitizers (such as metformin); * Insulin resistance or pre-diabetes condition * BMI \> 30 * Endocrinological alterations * Chronic pharmacological therapies * Major pathological conditions (e.g. tumors or autoimmune diseases)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of regular menstrual cycle | From enrollment (T0) to the completion of the study at 6 months (T6M) | Restoration of regular menstrual cycle will be assessed counting the days between two subsequent menstrual cycles, using a menstrual diary updated by the patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of physiological appearance of the ovaries at ultrasound | From enrollment (T0) to the completion of the study at 6 months (T6M) | Reduction of the ultrasonography count of arrested ovarian follicles |
Countries
Italy
Outcome results
None listed