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
1 other identifier
interventional
56
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 27, 2012
CompletedFirst Posted
Study publicly available on registry
February 6, 2012
CompletedFebruary 6, 2012
February 1, 2012
1 year
January 27, 2012
February 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome
six months
Study Arms (2)
Metformin
ACTIVE COMPARATOR850 mg/day twice a day
Metformin plus spironolactone
ACTIVE COMPARATORMetformin 850 mg twice a day for six months plus Spironolactone 25 mg day
Interventions
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
Eligibility Criteria
You may qualify if:
- Overweight/obese patients with PCOS
You may not qualify if:
- Other causes of hyperandrogenism and
- Use of drugs including:
- oral contraceptive
- anti-hypertensive agents
- anti-diabetic drugs
- agents for weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Mazza A, Fruci B, Guzzi P, D'Orrico B, Malaguarnera R, Veltri P, Fava A, Belfiore A. In PCOS patients the addition of low-dose spironolactone induces a more marked reduction of clinical and biochemical hyperandrogenism than metformin alone. Nutr Metab Cardiovasc Dis. 2014 Feb;24(2):132-9. doi: 10.1016/j.numecd.2013.04.016. Epub 2013 Jul 8.
PMID: 23845740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A. Mazza B. Fruci A. Belfiore, Doctors
Endocrinology Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
January 27, 2012
First Posted
February 6, 2012
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
July 1, 2011
Last Updated
February 6, 2012
Record last verified: 2012-02