Clinical trial · Interventional
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS
Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)
NCT02689843CI-TRIAL-00041556AntiPCOcompletedEarly Phase 1ClinicalTrials.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 aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation \[serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)\] levels.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyproterone compound + Spironolactone | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| Pioglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cyproterone compound + Spironolactone
- description
- Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily
- interventionNames
- Drug: Cyproterone compound + Spironolactone
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- Metformin 1500 mg daily
- interventionNames
- Drug: Metformin
- type
- ACTIVE_COMPARATOR
- label
- Pioglitazone
- description
- Pioglitazone 30 mg daily
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-35 years * Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required): 1. Oligomenorrhea or anovulation 2. Clinical and/or biochemical signs of hyperandrogenism 3. Polycystic ovaries (by ultrasound) Exclusion Criteria: * Smoking * Pregnancy * Diabetes mellitus * Renal failure (serum creatinine \>1.5) * Congenital adrenal hyperplasia * Hyper or hypothyroidism * Sex hormone therapy or antiandrogen therapy during the last three months * Unexplained serum alanin aminotransferase (ALT) elevation more than 2.5 times above normal range * Any systemic or febrile illnesses * Use of glucocorticoid or anti-inflammatory drugs during the last three months * Androgen secreting tumor * Malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.