Clinical trial · Interventional
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
NCT01526616CI-TRIAL-00006204completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Metformin plus Spironolactone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- 850 mg/day twice a day
- interventionNames
- Drug: Metformin
- type
- ACTIVE_COMPARATOR
- label
- Metformin plus spironolactone
- description
- Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
- interventionNames
- Drug: Metformin plus Spironolactone
Primary outcomes (1)
- measure
- Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
- timeFrame
- six months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMazza 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 23845740