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Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metformin
Metformin plus Spironolactone
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, metformin, spironolactone, metabolic syndrome, hyperandrogenism

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Overweight/obese patients with PCOS

Exclusion Criteria:

  • Other causes of hyperandrogenism and

  • Use of drugs including:

    • oral contraceptive
    • anti-hypertensive agents
    • anti-diabetic drugs
    • agents for weight loss

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Metformin

    Metformin plus spironolactone

    Arm Description

    850 mg/day twice a day

    Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day

    Outcomes

    Primary Outcome Measures

    Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
    We evaluated metabolic parameters across anthropometric parameters: height, weight, waist circumference, BMI, glycemia, lipid profile, blood count, coagulation parameters, hepatic and renal function indexes, OGTT and HOMA-IR. The diagnosis of MetS was established according to the ATPIII criteria

    Secondary Outcome Measures

    Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome
    We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, Δ4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.

    Full Information

    First Posted
    January 27, 2012
    Last Updated
    February 3, 2012
    Sponsor
    University Magna Graecia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01526616
    Brief Title
    Spironolactone Plus Metformin in Polycystic Ovary Syndrome
    Official Title
    Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Magna Graecia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.
    Detailed Description
    In the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of PCOS patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    PCOS, metformin, spironolactone, metabolic syndrome, hyperandrogenism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metformin
    Arm Type
    Active Comparator
    Arm Description
    850 mg/day twice a day
    Arm Title
    Metformin plus spironolactone
    Arm Type
    Active Comparator
    Arm Description
    Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    Metformin 850 mg twice a day for six months
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin plus Spironolactone
    Intervention Description
    Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
    Primary Outcome Measure Information:
    Title
    Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
    Description
    We evaluated metabolic parameters across anthropometric parameters: height, weight, waist circumference, BMI, glycemia, lipid profile, blood count, coagulation parameters, hepatic and renal function indexes, OGTT and HOMA-IR. The diagnosis of MetS was established according to the ATPIII criteria
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome
    Description
    We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, Δ4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.
    Time Frame
    six months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Overweight/obese patients with PCOS Exclusion Criteria: Other causes of hyperandrogenism and Use of drugs including: oral contraceptive anti-hypertensive agents anti-diabetic drugs agents for weight loss
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    A. Mazza B. Fruci A. Belfiore, Doctors
    Organizational Affiliation
    Endocrinology Unit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23845740
    Citation
    Mazza A, Fruci B, Guzzi P, D'Orrico B, Malaguarnera R, Veltri P, Fava A, Belfiore A. In PCOS patients the addition of low-dose spironolactone induces a more marked reduction of clinical and biochemical hyperandrogenism than metformin alone. Nutr Metab Cardiovasc Dis. 2014 Feb;24(2):132-9. doi: 10.1016/j.numecd.2013.04.016. Epub 2013 Jul 8.
    Results Reference
    derived

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    Spironolactone Plus Metformin in Polycystic Ovary Syndrome

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