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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00439972
First received: February 22, 2007
Last updated: February 10, 2011
Last verified: February 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
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.
Active Comparator: Group 2
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.
Active Comparator: Group 3
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.
Active Comparator: Group 4
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.
Active Comparator: Group 5
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.
Active Comparator: Group 6
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:

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

Exclusion Criteria:

  1. Blood pressure above 140/90 mmHg
  2. Glucose greater than 126 mg/dL or diabetes mellitus
  3. Triglyceride greater than 300 mg/dL
  4. Body mass index (BMI) greater than 30 kg/m2 or greater than 18.5 kg/m2
  5. Current or past history of thrombophlebitis, deep vein thrombosis or thromboembolic disorders.
  6. Current or past history of cerebrovascular or coronary artery disease.
  7. Presence of valvular heart disease with complications.
  8. Major surgery with prolonged immobilization.
  9. Known or suspected carcinoma of the breast or personal history of breast cancer.
  10. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
  11. Undiagnosed abnormal genital bleeding.
  12. History of cholestatic jaundice during pregnancy or history of jaundice with prior hormonal contraceptive use.
  13. Acute or chronic hepatocellular disease with abnormal liver function. Hepatic adenomas or carcinomas.
  14. Any active liver or renal disease.
  15. Untreated thyroid disease.
  16. Migraine or headaches with focal neurological symptoms.
  17. Known or suspected pregnancy or currently breast feeding.
  18. Alcohol intake above one drink per day
  19. Cigarette smoking
  20. Depression or any psychiatric illness
  21. Any lipid lowering or blood pressure lowering medication
  22. Any illegal drug use
  23. Non-steroidal anti-inflammatory drug (NSAID) or aspirin use for 5 days prior to vascular reactivity studies.
  24. Antioxidant supplements (stable multivitamin use allowed)
  25. History of sensitivity or allergic reaction to any hormonal contraceptives.
  26. Unwilling or unable to comply with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Robert H. Knopp, MD/Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00439972     History of Changes
Other Study ID Numbers: 28565-D
Study First Received: February 22, 2007
Last Updated: February 10, 2011
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

Additional relevant MeSH terms:
Ethinyl Estradiol
Moxifloxacin
Norelgestromin
Norgestimate, ethinyl estradiol drug combination
Norgestrel
Ortho Evra
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Enzyme Inhibitors
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014