Effects of Alpha-acid Lipoic in PCOS Women

Catholic University of the Sacred Heart40 enrolled

Overview

The aim of our study is to investigate the effects of six months treatment with alpha-lipoic acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral glucose tolerance test and hormonal assays are evaluated before and after therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

Alpha-lipoic acidDRUG

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 diseases * diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) * hypertension * significant liver or renal impairment * other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal) * neoplasms.

Outcomes

Primary Outcomes

Number of cycles in six months of therapy

Time frame: 6 months

Secondary Outcomes

Hirsutism score

Ferriman-Gallwey score

Time frame: 6 months

Insulin levels

Time frame: 6 months

androstenedione levels

Time frame: 6 months

testosterone levels

Time frame: 6 months

free androgen index

Time frame: 6 months

total cholesterol

Time frame: 6 months

LDL-cholesterol

Time frame: 6 months

tryglycerides levels

Time frame: 6 months

DHEAS levels

Time frame: 6 months

AMH levels

Time frame: 6 months

Data from ClinicalTrials.gov

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