Effects of Alpha-acid Lipoic in PCOS Women

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Alpha-lipoic acid

• Registration Number: NCT02666170
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Primary Completion: 2016-09

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy with alpha-lipoic acid daily for six months	Alpha-lipoic acid	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hirsutism score	6 months	Ferriman-Gallwey score
Insulin levels	6 months
androstenedione levels	6 months
testosterone levels	6 months
free androgen index	6 months
LDL-cholesterol	6 months
total cholesterol	6 months
tryglycerides levels	6 months
DHEAS levels	6 months
AMH levels	6 months