Effects of Alpha-acid Lipoic in PCOS Women

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Alpha-lipoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02666170

Alpha-Lipoic Acid 2016

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

therapy with alpha-lipoic acid daily for six months

Experimental group

Treatment:

Drug: Alpha-lipoic acid