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Spironolactone Plus Metformin in Polycystic Ovary Syndrome

This study has been completed.
Information provided by (Responsible Party):
Prof Antonino Belfiore, University Magna Graecia Identifier:
First received: January 27, 2012
Last updated: February 3, 2012
Last verified: February 2012
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.

Condition Intervention
Polycystic Ovary Syndrome Drug: Metformin Drug: Metformin plus Spironolactone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study

Resource links provided by NLM:

Further study details as provided by Prof Antonino Belfiore, University Magna Graecia:

Primary Outcome Measures:
  • Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study [ Time Frame: six months ]
    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 [ Time Frame: six months ]
    We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, Δ4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.

Enrollment: 56
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
850 mg/day twice a day
Drug: Metformin
Metformin 850 mg twice a day for six months
Active Comparator: Metformin plus spironolactone
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
Drug: Metformin plus Spironolactone
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day

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.

Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01526616

Sponsors and Collaborators
University Magna Graecia
Principal Investigator: A. Mazza B. Fruci A. Belfiore, Doctors Endocrinology Unit
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof Antonino Belfiore, Full Professor, University Magna Graecia Identifier: NCT01526616     History of Changes
Other Study ID Numbers: 2010.31
Study First Received: January 27, 2012
Last Updated: February 3, 2012

Keywords provided by Prof Antonino Belfiore, University Magna Graecia:
metabolic syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on September 19, 2017