Spironolactone Plus Metformin in Polycystic Ovary Syndrome
NCT ID: NCT01526616
Last Updated: 2012-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
56 participants
INTERVENTIONAL
2010-05-31
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)
NCT05394142
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
NCT00842140
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
NCT01791647
Metformin Administration in Infertile Anovulatory PCOS Patients
NCT00501787
A Treatment Legacy Effect of Metformin in Obese Women With PCOS
NCT04566718
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin
850 mg/day twice a day
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
Metformin plus Spironolactone
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Use of drugs including:
* oral contraceptive
* anti-hypertensive agents
* anti-diabetic drugs
* agents for weight loss
16 Years
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Magna Graecia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof Antonino Belfiore
Full Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
A. Mazza B. Fruci A. Belfiore, Doctors
Role: PRINCIPAL_INVESTIGATOR
Endocrinology Unit
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010.31
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.