Birth Control Pill vs Birth Control Patch Study (PvP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554632
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : November 7, 2007
University of Vermont Medical Center
Information provided by:
University of Vermont

Brief Summary:
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 or disease Intervention/treatment Phase
Venous Thrombosis Drug: Ethinyl estradiol and norgestimate Drug: Ethinyl estradiol and norelgestromin Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Oral Contraceptive Pills vs Hormonal Patch on Coagulation Parameters
Study Start Date : April 2003
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554632

Sponsors and Collaborators
University of Vermont
University of Vermont Medical Center
Principal Investigator: Julia V Johnson, MD Fletcher Allen Health Care & University of Vermont

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00554632     History of Changes
Other Study ID Numbers: 03-168
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: November 7, 2007
Last Verified: October 2007

Keywords provided by University of Vermont:
Venous thrombosis
Coagulation parameter

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