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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526616

Enrollment

Registered

2012-02-06

Start date

2010-05-31

Completion date

2011-07-31

Last updated

2012-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, metformin, spironolactone, metabolic syndrome, hyperandrogenism

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.

Interventions

DRUGMetformin

Metformin 850 mg twice a day for six months

DRUGMetformin plus Spironolactone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study	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

Measure	Time frame	Description
Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome	six months	We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, Δ4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026