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

Not Applicable

Completed

• Conditions: Hyperandrogenism; Metabolic Features; Menstrual Pattern; Polycystic Ovary Syndrome
• Interventions: Drug: myo-inositol,alpha-lipoic acid and folic acid

• Registration Number: NCT02651636
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-07
• Study First Submitted: 2015-11-27
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-11
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label	myo-inositol,alpha-lipoic acid and folic acid	Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months

Primary Outcome Measures

Name	Time	Method
Number of cycles in six months of therapy	6 months

Secondary Outcome Measures

Name	Time	Method
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