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Trial Title:
Treatment of Women with PCOS of Phenotype D
NCT ID:
NCT06639698
Condition:
PCOS (Polycystic Ovary Syndrome)
Conditions: Official terms:
Polycystic Ovary Syndrome
Conditions: Keywords:
PCOS phenotype D
Diosgenin
Dioscorea
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Diosgenin
Description:
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
Arm group label:
Treatment
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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Alma Res Fertility Center
Address:
City:
Rome
Zip:
00198
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cesare Aragona, MD
Phone:
+39 348 4043527
Email:
almares@almares.it
Start date:
October 14, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Lo.Li.Pharma s.r.l
Agency class:
Industry
Source:
Lo.Li.Pharma s.r.l
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06639698
