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Spironolactone Plus Metformin in Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT01526616
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : February 6, 2012
Sponsor:
Information provided by (Responsible Party):
Prof Antonino Belfiore, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Metformin plus Spironolactone Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526616


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

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
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Prof Antonino Belfiore, University Magna Graecia:
PCOS
metformin
spironolactone
metabolic syndrome
hyperandrogenism

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