Clinical trial · Interventional
Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS
NCT01459445CI-TRIAL-00005681unknownN/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 purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum hsCRP,lipids,insulin resistance and body composition in young women with PCOS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endothelial Dysfunction | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin, Ethinylestradiol 30µg-Drospirenone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Metformin+Drospirenone / EE 30µg
- interventionNames
- Drug: Metformin, Ethinylestradiol 30µg-Drospirenone
Primary outcomes (1)
- measure
- flow-mediated dilation
- timeFrame
- six months
Secondary outcomes (8)
- measure
- endothelin-1
- timeFrame
- six months
- measure
- hsCRP
- timeFrame
- six months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * women with diagnosis of polycystic ovary syndrome defined according to Androgen Excess Society 2006 guidelines Exclusion Criteria: * secondary causes of hyperandrogenism such as hyperprolactinemia, thyroid disease, androgen-secreting tumours, Cushing's syndrome and congenital adrenal hyperplasia * current or previous use (within 6 months) of oral contraceptives, anti-androgens, ovulation induction medications * use of drugs known to affect carbohydrate-lipid metabolism or inflammation (anti-inflammatory drugs) at the time of evaluation and during the last one month preceding the evaluations * concurrent minor infection reported during the last one month preceding the evaluations * personal history of diabetes mellitus
References
Publications (1)
- DERIVEDIlie IR, Marian I, Mocan T, Ilie R, Mocan L, Duncea I, Pepene CE. Ethinylestradiol30mug-drospirenone and metformin: could this combination improve endothelial dysfunction in polycystic ovary syndrome? BMC Endocr Disord. 2012 Jun 19;12:9. doi: 10.1186/1472-6823-12-9. PMID 22713099