Spironolactone Plus Metformin in Polycystic Ovary Syndrome | RxWiki

Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Overview[ - collapse ][ - ]

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	Polycystic Ovary Syndrome
Intervention	Drug: Metformin Drug: Metformin plus Spironolactone
Phase	N/A
Sponsor	University Magna Graecia
Responsible Party	University Magna Graecia
ClinicalTrials.gov Identifier	NCT01526616
First Received	January 27, 2012
Last Updated	February 3, 2012
Last verified	February 2012

Tracking Information[ + expand ][ + ]

First Received Date	January 27, 2012
Last Updated Date	February 3, 2012
Start Date	May 2010
Estimated Primary Completion Date	July 2011
Current 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
Current 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.

Descriptive Information[ + expand ][ + ]

Brief Title	Spironolactone Plus Metformin in Polycystic Ovary Syndrome
Official Title	Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
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.
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
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome
Intervention	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
Study Arm (s)	Active Comparator: Metformin 850 mg/day twice a day Active Comparator: Metformin plus spironolactone Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	56
Estimated Completion Date	July 2011
Estimated Primary Completion Date	May 2011
Eligibility 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
Gender	Female
Ages	16 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01526616
Other Study ID Numbers	2010.31
Has Data Monitoring Committee	No
Information Provided By	University Magna Graecia
Study Sponsor	University Magna Graecia
Collaborators	Not Provided
Investigators	Principal Investigator: A. Mazza B. Fruci A. Belfiore, Doctors Endocrinology Unit
Verification Date	February 2012