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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651636
• Other study ID #: 000102014
• Status: Completed
• Phase: N/A
• First received: November 27, 2015
• Last updated: January 7, 2016
• Start date: June 2014

Study information

• Verified date: January 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Catholic University of Sacxred Heart
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperandrogenism
• Menstrual Pattern
• Metabolic Features
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cycles in six months of therapy		6 months	No
Secondary	Hirsutism	Ferriman Gallwey score	6 months	No
Secondary	Hyperandrogenism	Testosterone, Androstenedione, free androgen index	6 months	No
Secondary	Insulin response to oral glucose tolerance test		6 months	No
Secondary	Lipidic profile	Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride	6 months	No