Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome

Summary

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.

Timeline

Start

2011-02

Primary completion

2011-06

Completion

2012-01

Outcome

Mixed primary results

paper Primary outcome measures were surrogate markers of cardiovascular disease and included endothelial function, i.e. flow-mediated dilatation (FMD) on the brachial artery and endothelin-1 levels, as well as hsCRP concentrations, body composition PMID 22713099 ↗

paper triggered a significant improvement in the FMD values (FMD-PCOSbasal 3.48 ± 1.00 vs FMD-PCOS6 months7.43 ± 1.04, p = 0.033) PMID 22713099 ↗

paper Regarding hsCRP levels, there was no significant intragroup (PCOS6months - PCOSbasal) difference. PMID 22713099 ↗

Publications

• Ilie 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1700 mg	—
Subject	drospirenone	Unknown	3 mg	Oral
Subject	ethinyl estradiol	Small molecule	30 ug	Oral

Indications