Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin; Drug: Metformin plus Spironolactone

• Registration Number: NCT01526616
• Lead Sponsor: University Magna Graecia

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-07
• Study First Submitted: 2012-01-27
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-03
• Last Update Submitted: 2012-02-03
• Study First Posted: 2012-02-06
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Overweight/obese patients with PCOS

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Exclusion Criteria

• Other causes of hyperandrogenism and

• Use of drugs including:

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	850 mg/day twice a day
Metformin plus spironolactone	Metformin plus Spironolactone	Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day

Primary Outcome Measures

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

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