Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526616
• Other study ID #: 2010.31
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: February 3, 2012
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: February 2012
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study	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	six months	No
Secondary	Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome	We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, ?4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.	six months	No