Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity - Full Text View

Sponsors and Collaborators:	University of Washington Ortho-McNeil Pharmaceutical
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00439972

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: Ortho-Cyclen (R) Drug: Ortho Evra (R) Drug: extended use of Ortho Evra (R)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Comparison of Oral and Patch Forms of Hormonal Contraception on Plasma Lipoproteins, Glycemia, Clotting Factors, Indices of Inflammation and Vascular Reactivity

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Birth Control

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Ortho Evra

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Glucose, insulin, lipoproteins, clotting factors, hormone levels and sex hormone binding globulin [ Time Frame: measured at baseline and days 1, 7, 21 and 28 of study months 2, 4 and 6 ] [ Designated as safety issue: No ]
inflammatory proteins, apoproteins and total antioxidant capacity [ Time Frame: measured at baseline and days 1 and 21 of study months 2, 4 and 6 ] [ Designated as safety issue: No ]
vascular reactivity [ Time Frame: measured at baseline and day 21 of study months 2, 4 and 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Visits 2-6: Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: extended use of Ortho Evra (R)	Drug: Ortho-Cyclen (R) The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study. Drug: Ortho Evra (R) Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study. Drug: extended use of Ortho Evra (R) The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
Group 2: Active Comparator Visits 2-6: Ortho Evra (R) Visits 6-11: extended use Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)	Drug: Ortho-Cyclen (R) The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study. Drug: Ortho Evra (R) Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study. Drug: extended use of Ortho Evra (R) The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
Group 3: Active Comparator Visits 2-6: Ortho Cyclen (R) Visits 6-11: Ortho Evra (R) Visits 11-15: extended use of Ortho Evra (R)	Drug: Ortho-Cyclen (R) The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study. Drug: Ortho Evra (R) Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study. Drug: extended use of Ortho Evra (R) The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
Group 4: Active Comparator Visits 2-6: Ortho Cyclen (R) Visits 6-11: extended use of Ortho Evra (R) Visits 11-15: Ortho Evra (R)	Drug: Ortho-Cyclen (R) The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study. Drug: Ortho Evra (R) Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study. Drug: extended use of Ortho Evra (R) The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
Group 5: Active Comparator Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)	Drug: Ortho-Cyclen (R) The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study. Drug: Ortho Evra (R) Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study. Drug: extended use of Ortho Evra (R) The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
Group 6: Active Comparator Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: Ortho Evra (R)	Drug: Ortho-Cyclen (R) The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study. Drug: Ortho Evra (R) Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study. Drug: extended use of Ortho Evra (R) The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439972

Locations

United States, Washington
University of Washington, Northwest Lipid Research Clinic
Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

Ortho-McNeil Pharmaceutical

Investigators

Principal Investigator:

Robert H Knopp, MD

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Robert H. Knopp, MD/Professor of Medicine )
Study ID Numbers:	058043D
Study First Received:	February 22, 2007
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00439972 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Lipoproteins
Apolipoproteins
Insulin sensitivity
Inflammation

Clotting
Antioxidant status
Vascular reactivity
Metabolism

Study placed in the following topic categories:

Anti-Infective Agents
Norelgestromin
Antioxidants
Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Hormones

Insulin
Estradiol
Inflammation
Contraceptives, Oral, Combined
Norgestimate
Moxifloxacin
Estradiol 3-benzoate
Ortho Evra
Polyestradiol phosphate

Additional relevant MeSH terms:

Contraceptives, Oral, Combined
Anti-Infective Agents
Contraceptive Agents
Moxifloxacin
Therapeutic Uses
Physiological Effects of Drugs

Contraceptives, Oral
Contraceptive Agents, Female
Ortho Evra
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009