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

Status unconfirmed · Phase 2

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT00439972

Run by

University of Washington

People needed

36

Starts

2007-02-01

Expected to finish

2011-12-01

Last updated by the study team

2011-02-14

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Willing to participate in a crossover design study with biweekly or weekly clinic visits in the second, fourth and sixth months.
• Healthy women within the age range of 18 to 50 years inclusive who are sexually active and at risk for pregnancy.

You may not qualify if…

• Blood pressure above 140/90 mmHg
• Glucose greater than 126 mg/dL or diabetes mellitus
• Triglyceride greater than 300 mg/dL
• Body mass index (BMI) greater than 30 kg/m2 or greater than 18.5 kg/m2
• Current or past history of thrombophlebitis, deep vein thrombosis or thromboembolic disorders.
• Current or past history of cerebrovascular or coronary artery disease.
• Presence of valvular heart disease with complications.
• Major surgery with prolonged immobilization.
• Known or suspected carcinoma of the breast or personal history of breast cancer.
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
• Undiagnosed abnormal genital bleeding.
• History of cholestatic jaundice during pregnancy or history of jaundice with prior hormonal contraceptive use.
• Acute or chronic hepatocellular disease with abnormal liver function. Hepatic adenomas or carcinomas.
• Any active liver or renal disease.
• Untreated thyroid disease.
• Migraine or headaches with focal neurological symptoms.
• Known or suspected pregnancy or currently breast feeding.
• Alcohol intake above one drink per day
• Cigarette smoking
• Depression or any psychiatric illness
• Any lipid lowering or blood pressure lowering medication
• Any illegal drug use
• Non-steroidal anti-inflammatory drug (NSAID) or aspirin use for 5 days prior to vascular reactivity studies.
• Antioxidant supplements (stable multivitamin use allowed)
• History of sensitivity or allergic reaction to any hormonal contraceptives.

Where it is running

• University of Washington, Northwest Lipid Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.