Birth Control Pill vs Birth Control Patch Study - Full Text View

Sponsor:	University of Vermont
Collaborator:	Fletcher Allen Health Care
Information provided by:	University of Vermont
ClinicalTrials.gov Identifier:	NCT00554632

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:

MedlinePlus related topics: Birth Control Deep Vein Thrombosis

Drug Information available for: Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Norgestimate Norelgestromin

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

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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):

Johnson JV, Lowell J, Badger GJ, Rosing J, Tchaikovski S, Cushman M. Effects of oral and transdermal hormonal contraception on vascular risk markers: a randomized controlled trial. Obstet Gynecol. 2008 Feb;111(2 Pt 1):278-84.

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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
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 May 24, 2012