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Birth Control Pill vs Birth Control Patch Study

NCT00554632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2007-11-07

No results posted yet for this study

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).

Conditions

  • Venous Thrombosis

Interventions

DRUG

Ethinyl estradiol and norgestimate

Oral contraceptive

DRUG

Ethinyl estradiol and norelgestromin

Transdermal hormonal contraceptive changed weekly

Sponsors & Collaborators

  • University of Vermont Medical Center

    collaborator OTHER

  • University of Vermont

    lead OTHER

Principal Investigators

  • Julia V Johnson, MD · Fletcher Allen Health Care & University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Completion
2005-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554632 on ClinicalTrials.gov