Spironolactone Plus Metformin in Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof Antonino Belfiore, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01526616
First received: January 27, 2012
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01526616

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

No publications provided by University Magna Graecia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Antonino Belfiore, Full Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01526616     History of Changes
Other Study ID Numbers: 2010.31
Study First Received: January 27, 2012
Last Updated: February 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
PCOS
metformin
spironolactone
metabolic syndrome
hyperandrogenism

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes
Metformin
Spironolactone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014