Status:
UNKNOWN
Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Ortho-McNeil Pharmaceutical
Conditions:
Contraception
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Study Rationale: The metabolic effects of hormonal contraceptives differ when administered by oral or systemic routes. The oral route magnifies the hepatic production of hormone sensitive proteins in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Unwilling or unable to comply with the study protocol
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00439972
Start Date
February 1 2007
End Date
December 1 2011
Last Update
February 14 2011
Active Locations (1)
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1
University of Washington, Northwest Lipid Research Clinic
Seattle, Washington, United States, 98104