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Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Information source: University Magna Graecia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: Metformin (Drug); Metformin plus Spironolactone (Drug)

Phase: N/A

Status: Completed

Sponsored by: University Magna Graecia

Official(s) and/or principal investigator(s):
A. Mazza B. Fruci A. Belfiore, Doctors, Principal Investigator, Affiliation: Endocrinology Unit


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.

Clinical Details

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

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

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

Secondary outcome: Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome

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.


Minimum age: 16 Years. Maximum age: 35 Years. Gender(s): Female.


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

Locations and Contacts

Additional Information

Starting date: May 2010
Last updated: February 3, 2012

Page last updated: August 23, 2015

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