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Pharmacokinetics of Implanon in Obese Women

NCT00724438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2013-09-05

No results posted yet for this study

Summary

Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Melissa Gilliam, MD, MPH · University of Chicago

  • Sara J Mornar, DO · University of Chicago

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-08-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00724438 on ClinicalTrials.gov