drugset / Trial / NCT00439972

Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity

NCT00439972

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.

Timeline

Start
2007-02
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Norgestimate Small molecule 250 ug Oral
Comparator ethinyl estradiol Small molecule 35 ug Oral
Comparator ethinyl estradiol Small molecule 0.75 mg Oral
Comparator norelgestromin Unknown 6 mg Other

Indications

No indication recorded.