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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome Menstrual Pattern Hyperandrogenism Metabolic Features

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open label

Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months

Group Type EXPERIMENTAL

myo-inositol,alpha-lipoic acid and folic acid

Intervention Type DRUG

Interventions

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myo-inositol,alpha-lipoic acid and folic acid

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No