NCT00554632

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2003

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
Last Updated

November 7, 2007

Status Verified

October 1, 2007

First QC Date

November 6, 2007

Last Update Submit

November 6, 2007

Conditions

Venous Thrombosis

Keywords

ContraceptiveVenous thrombosisCoagulation parameter

Outcome Measures

Primary Outcomes (1)

  • Change in coagulation parameters on transdermal versus oral contraceptive

    2003--2005

Secondary Outcomes (1)

  • Compare ethinyl estradiol levels for transdermal versus oral contraceptives

    September 2007

Study Arms (2)

1

ACTIVE COMPARATOR

Use of transdermal hormonal contraceptive

Drug: Ethinyl estradiol and norelgestromin

2

ACTIVE COMPARATOR

Use of oral hormonal contraceptive

Drug: Ethinyl estradiol and norgestimate

Interventions

Ethinyl estradiol and norgestimateDRUG

Oral contraceptive

Also known as: Ortho Cyclen
2
Ethinyl estradiol and norelgestrominDRUG

Transdermal hormonal contraceptive changed weekly

Also known as: Ortho Evra
1

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1097/AOG.0b013e3181626d1b.

    PMID: 18238963DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

norgestimate, ethinyl estradiol drug combinationMoxifloxacinEthinyl EstradiolnorelgestrominOrtho Evra

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Julia V Johnson, MD

    Fletcher Allen Health Care & University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 7, 2007

Study Start

April 1, 2003

Study Completion

August 1, 2005

Last Updated

November 7, 2007

Record last verified: 2007-10