drugset / Trial / NCT00439972
Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.