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

Catholic University of the Sacred Heart

Status: Completed

Conditions: Hyperandrogenism; Metabolic Features; Polycystic Ovary Syndrome; Menstrual Pattern

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02651636

000102014

Details and patient eligibility

About

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.

Enrollment: 40 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 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.

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

Open label

Experimental group

Description:

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

Treatment:

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