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

NCT00439972 | Unknown Phase 2 DMC

• 1 other identifier: 28565-D
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Contraception

Keywords

Lipoproteins; Apolipoproteins; Insulin sensitivity; Inflammation; Clotting; Antioxidant status; Vascular reactivity; Metabolism

Outcome Measures

Primary Outcomes (3)

• Glucose, insulin, lipoproteins, clotting factors, hormone levels and sex hormone binding globulin

  measured at baseline and days 1, 7, 21 and 28 of study months 2, 4 and 6

• inflammatory proteins, apoproteins and total antioxidant capacity

  measured at baseline and days 1 and 21 of study months 2, 4 and 6

• vascular reactivity

  measured at baseline and day 21 of study months 2, 4 and 6

Study Arms (6)

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); Drug: Ortho Evra (R); Drug: extended use of Ortho Evra (R)

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); Drug: Ortho Evra (R); Drug: extended use of Ortho Evra (R)

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); Drug: Ortho Evra (R); Drug: extended use of Ortho Evra (R)

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); Drug: Ortho Evra (R); Drug: extended use of Ortho Evra (R)

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); Drug: Ortho Evra (R); Drug: extended use of Ortho Evra (R)

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); Drug: Ortho Evra (R); Drug: extended use of Ortho Evra (R)

Interventions

Ortho-Cyclen (R) DRUG

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.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Ortho Evra (R) DRUG

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.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

extended use of Ortho Evra (R) DRUG

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 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Washington: lead
• Ortho-McNeil Pharmaceutical: collaborator

Study Sites (1)

University of Washington, Northwest Lipid Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Inflammation; Thrombosis

Interventions

Moxifloxacin; Ortho Evra

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert H Knopp, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 14, 2011

Record last verified: 2011-02

Locations

US (1)