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Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study


N/A
16 Years
35 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study

Outcome 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

Outcome Time Frame:

six months

Safety Issue:

No

Principal Investigator

A. Mazza B. Fruci A. Belfiore, Doctors

Investigator Role:

Principal Investigator

Investigator Affiliation:

Endocrinology Unit

Authority:

Italy: Ethics Committee

Study ID:

2010.31

NCT ID:

NCT01526616

Start Date:

May 2010

Completion Date:

July 2011

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • metformin
  • spironolactone
  • metabolic syndrome
  • hyperandrogenism
  • Polycystic Ovary Syndrome

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