Working… Menu
Trial record 79 of 579 for:    "Polycystic Ovary Syndrome"

Spironolactone Plus Metformin in Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526616
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : February 6, 2012
Information provided by (Responsible Party):
Prof Antonino Belfiore, University Magna Graecia

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Metformin plus Spironolactone Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Metformin
850 mg/day twice a day
Drug: Metformin
Metformin 850 mg twice a day for six months

Active Comparator: Metformin plus spironolactone
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
Drug: Metformin plus Spironolactone
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day

Primary Outcome Measures :
  1. Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study [ Time Frame: 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 Outcome Measures :
  1. Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome [ Time Frame: six months ]
    We evaluated hyperandrogenism across Hirsutism Score, measuring total testosterone, SHBG, Δ4androstenedione, DHEA-S and FAI. All patients underwent ovarian ultrasound examination.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526616

Sponsors and Collaborators
University Magna Graecia
Layout table for investigator information
Principal Investigator: A. Mazza B. Fruci A. Belfiore, Doctors Endocrinology Unit

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof Antonino Belfiore, Full Professor, University Magna Graecia Identifier: NCT01526616     History of Changes
Other Study ID Numbers: 2010.31
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012
Keywords provided by Prof Antonino Belfiore, University Magna Graecia:
metabolic syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents