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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT02651636

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Menstrual Pattern Hyperandrogenism Metabolic Features	Drug: myo-inositol,alpha-lipoic acid and folic acid	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open label Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months	Drug: myo-inositol,alpha-lipoic acid and folic acid

Arm

Intervention/Treatment

Experimental: Open label

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

Drug: myo-inositol,alpha-lipoic acid and folic acid

Outcome Measures

Primary Outcome Measures

Number of cycles in six months of therapy [6 months]

Secondary Outcome Measures

Hirsutism [6 months]
Ferriman Gallwey score
Hyperandrogenism [6 months]
Testosterone, Androstenedione, free androgen index
Insulin response to oral glucose tolerance test [6 months]
Lipidic profile [6 months]
Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.