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Effects of Alpha-acid Lipoic in PCOS Women

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alpha-lipoic 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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    therapy with alpha-lipoic acid daily for six months

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of cycles in six months of therapy

    Secondary Outcome Measures

    Hirsutism score
    Ferriman-Gallwey score
    Insulin levels
    androstenedione levels
    testosterone levels
    free androgen index
    total cholesterol
    LDL-cholesterol
    tryglycerides levels
    DHEAS levels
    AMH levels

    Full Information

    First Posted
    January 21, 2016
    Last Updated
    January 26, 2016
    Sponsor
    Catholic University of the Sacred Heart
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02666170
    Brief Title
    Effects of Alpha-acid Lipoic in PCOS Women
    Official Title
    Effects of 6 Months of Alpha-Lipoic Acid Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome

    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 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    therapy with alpha-lipoic acid daily for six months
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Alpha-lipoic acid
    Primary Outcome Measure Information:
    Title
    Number of cycles in six months of therapy
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Hirsutism score
    Description
    Ferriman-Gallwey score
    Time Frame
    6 months
    Title
    Insulin levels
    Time Frame
    6 months
    Title
    androstenedione levels
    Time Frame
    6 months
    Title
    testosterone levels
    Time Frame
    6 months
    Title
    free androgen index
    Time Frame
    6 months
    Title
    total cholesterol
    Time Frame
    6 months
    Title
    LDL-cholesterol
    Time Frame
    6 months
    Title
    tryglycerides levels
    Time Frame
    6 months
    Title
    DHEAS levels
    Time Frame
    6 months
    Title
    AMH levels
    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 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.

    12. IPD Sharing Statement

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