Spironolactone Plus Metformin in Polycystic Ovary Syndrome

University Magna Graecia

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Drug: Metformin plus Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT01526616

2010.31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Metformin

Active Comparator group

Description:

850 mg/day twice a day

Treatment:

Drug: Metformin

Metformin plus spironolactone

Active Comparator group

Description:

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

Treatment:

Drug: Metformin plus Spironolactone