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Birth Control Pill vs Birth Control Patch Study (PvP)

This study has been completed.
Sponsor:
Collaborator:
Fletcher Allen Health Care
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00554632
First received: November 6, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

This study was a randomized, investigator-blinded, cross-over, clinic trial using twenty-four healthy women aged 18-35. All women received two months of the birth control patch or birth control pill, two months without any drug, then two months of the alternative drug. The birth control patch contained 0.75 milligrams ethinyl estradiol and 6 milligrams norelgestromin. The birth control pill contained 35 micrograms ethinyl estradiol and 250 micrograms norgestimate. Blood samples were taken before and after each treatment and were analyzed for the following lab values: D-dimer, von Willebrand factor, factor VIII, total and free protein S, antithrombin, fibrinogen, C-reactive protein and normalized activated protein C sensitivity ratio (nAPCsr). Two thrombin generation-based assays were used: the α2macroglobulin-thrombin endpoint method (α2M-IIa) and calibrated automated thrombinography (CAT).


Condition Intervention
Venous Thrombosis
 Drug: Ethinyl estradiol and norgestimate
Drug: Ethinyl estradiol and norelgestromin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Oral Contraceptive Pills vs Hormonal Patch on Coagulation Parameters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Change in coagulation parameters on transdermal versus oral contraceptive [ Time Frame: 2003--2005 ]

Secondary Outcome Measures:
  • Compare ethinyl estradiol levels for transdermal versus oral contraceptives [ Time Frame: September 2007 ]

Enrollment: 24
Study Start Date: April 2003
Study Completion Date: August 2005
Arms Assigned Interventions
Active Comparator: 1
Use of transdermal hormonal contraceptive
 Drug: Ethinyl estradiol and norelgestromin
Transdermal hormonal contraceptive changed weekly
Other Name: Ortho Evra
Active Comparator: 2
Use of oral hormonal contraceptive
 Drug: Ethinyl estradiol and norgestimate
Oral contraceptive
Other Name: Ortho Cyclen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ages 18-35 years of age
  • Not on hormones for at least 2 months prior to enrollment
  • Must be more than 3 months post-partum, &
  • Generally healthy.

Exclusion Criteria:

  • Women with prior history of contraindications to taking birth control pills
  • History of Deep Vein Thrombosis or Pulmonary Embolism
  • Known history of coagulation disorders
  • Liver disease
  • Pregnant or actively attempting pregnancy
  • Currently breastfeeding
  • Uncontrolled hypertension
  • Migraines with ischemic changes, &
  • Weight more than 199 lbs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554632

Sponsors and Collaborators
University of Vermont
Fletcher Allen Health Care
Investigators
Principal Investigator: Julia V Johnson, MD Fletcher Allen Health Care & University of Vermont
  More Information

No publications provided by University of Vermont

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00554632     History of Changes
Other Study ID Numbers: 03-168
Study First Received: November 6, 2007
Last Updated: November 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Contraceptive
Venous thrombosis
Coagulation parameter

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norgestimate
Norelgestromin
Contraceptives, Oral
 Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on June 17, 2013