Text Size

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
History of Changes

January 27, 2012
February 3, 2012
May 2010
May 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01526616 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Spironolactone Plus Metformin in Polycystic Ovary Syndrome
Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Metformin
    Metformin 850 mg twice a day for six months
  • Drug: Metformin plus Spironolactone
    Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
  • Active Comparator: Metformin
    850 mg/day twice a day
    Intervention: Drug: Metformin
  • Active Comparator: Metformin plus spironolactone
    Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
    Intervention: Drug: Metformin plus Spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
July 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
16 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01526616
2010.31
No
Prof Antonino Belfiore, University Magna Graecia
University Magna Graecia
Not Provided
Principal Investigator: A. Mazza B. Fruci A. Belfiore, Doctors Endocrinology Unit
University Magna Graecia
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP