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

PHASE2UnknownINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Contraception
Interventions
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.

Trial Locations (1)

98104

University of Washington, Northwest Lipid Research Clinic, Seattle

Sponsors
All Listed Sponsors
collaborator

Ortho-McNeil Pharmaceutical

INDUSTRY

lead

University of Washington

OTHER