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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Ortho-McNeil Pharmaceutical
• Treatments: Ethinyl Estradiol; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ortho Evra

Criteria

Inclusion Criteria:

1. Willing to participate in a crossover design study with biweekly or weekly clinic visits in the second, fourth and sixth months.

2. Healthy women within the age range of 18 to 50 years inclusive who are sexually active and at risk for pregnancy.

Exclusion Criteria:

1. Blood pressure above 140/90 mmHg

2. Glucose greater than 126 mg/dL or diabetes mellitus

3. Triglyceride greater than 300 mg/dL

4. Body mass index (BMI) greater than 30 kg/m2 or greater than 18.5 kg/m2

5. Current or past history of thrombophlebitis, deep vein thrombosis or thromboembolic disorders.

6. Current or past history of cerebrovascular or coronary artery disease.

7. Presence of valvular heart disease with complications.

8. Major surgery with prolonged immobilization.

9. Known or suspected carcinoma of the breast or personal history of breast cancer.

10. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.

11. Undiagnosed abnormal genital bleeding.

12. History of cholestatic jaundice during pregnancy or history of jaundice with prior hormonal contraceptive use.

13. Acute or chronic hepatocellular disease with abnormal liver function. Hepatic adenomas or carcinomas.

14. Any active liver or renal disease.

15. Untreated thyroid disease.

16. Migraine or headaches with focal neurological symptoms.

17. Known or suspected pregnancy or currently breast feeding.

18. Alcohol intake above one drink per day

19. Cigarette smoking

20. Depression or any psychiatric illness

21. Any lipid lowering or blood pressure lowering medication

22. Any illegal drug use

23. Non-steroidal anti-inflammatory drug (NSAID) or aspirin use for 5 days prior to vascular reactivity studies.

24. Antioxidant supplements (stable multivitamin use allowed)

25. History of sensitivity or allergic reaction to any hormonal contraceptives.

26. Unwilling or unable to comply with the study protocol