Treatment of Women with PCOS of Phenotype D (PT-PHD)

Lo.Li.Pharma

Status: Enrolling

Conditions: PCOS (Polycystic Ovary Syndrome)

Treatments: Dietary Supplement: Diosgenin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06639698

PILOT-PHD-129

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

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

Treatment:

Dietary Supplement: Diosgenin