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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
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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.

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

    First Posted
    November 27, 2015
    Last Updated
    January 7, 2016
    Sponsor
    Catholic University of the Sacred Heart
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    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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