Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women
Primary Purpose
Polycystic Ovary Syndrome, Menstrual Pattern, Hyperandrogenism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
myo-inositol,alpha-lipoic acid and folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label
Arm Description
Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months
Outcomes
Primary Outcome Measures
Number of cycles in six months of therapy
Secondary Outcome Measures
Hirsutism
Ferriman Gallwey score
Hyperandrogenism
Testosterone, Androstenedione, free androgen index
Insulin response to oral glucose tolerance test
Lipidic profile
Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride
Full Information
NCT ID
NCT02651636
First Posted
November 27, 2015
Last Updated
January 7, 2016
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT02651636
Brief Title
Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Menstrual Pattern, Hyperandrogenism, Metabolic Features
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label
Arm Type
Experimental
Arm Description
Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months
Intervention Type
Drug
Intervention Name(s)
myo-inositol,alpha-lipoic acid and folic acid
Primary Outcome Measure Information:
Title
Number of cycles in six months of therapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hirsutism
Description
Ferriman Gallwey score
Time Frame
6 months
Title
Hyperandrogenism
Description
Testosterone, Androstenedione, free androgen index
Time Frame
6 months
Title
Insulin response to oral glucose tolerance test
Time Frame
6 months
Title
Lipidic profile
Description
Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
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Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women
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