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Completed

NCT Number: NCT01526616

Spironolactone Plus Metformin in Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovary Syndrome 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperandrogenism Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Abnormalities Urogenital Diseases

Age range

16 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Metformin 850 mg twice a day for six months

Metformin plus Spironolactone

Drug

Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 6, 2012
Registry last updated
Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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