Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women

Catholic University of the Sacred Heart40 enrolled

Overview

The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome Menstrual Pattern Hyperandrogenism Metabolic Features

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women with PCOS in accordance with Rotterdam criteria Exclusion Criteria: * pregnancy * past history of cardiovascular disease, * diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), * hypertension, * significant liver or renal impairment, * other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs), * neoplasms, * unstable mental illness.

Outcomes

Primary Outcomes

Number of cycles in six months of therapy

Time frame: 6 months

Secondary Outcomes

Hirsutism

Ferriman Gallwey score

Time frame: 6 months

Hyperandrogenism

Testosterone, Androstenedione, free androgen index

Time frame: 6 months

Insulin response to oral glucose tolerance test

Time frame: 6 months

Lipidic profile

Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride

Time frame: 6 months