Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin
* Drug: Metformin plus Spironolactone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>850 mg/day twice a day | Drug: Metformin<br>* Metformin 850 mg twice a day for six months<br>|
| Active Comparator: Metformin plus spironolactone<br>Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day | Drug: Metformin plus Spironolactone<br>* Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, metformin, spironolactone, metabolic syndrome, hyperandrogenism