Pharmacokinetics of Implanon in Obese Women
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.
Status: Completed (N/A). Started on July 1st, 2008.
Enrollment: 18 subjects
Study Type: Observational
Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
Conditions:
Interventions:
Eligibility
Inclusion Criteria:
premenopausal with a uterus and at least one ovary
willing and able to sign the informed consent
willing to comply with the study protocol and visit schedule
have a body mass index of less than 25, or greater than or equal to 30
weight stable
Exclusion Criteria:
known or suspected pregnancy
delivery (vaginal or cesarean) within 4 months of device insertion
abortion (first or second trimester) within 4 months of device insertion
contraindications to Implanon use
undiagnosed abnormal genital bleeding
hypersensitivity or allergy to any components of Implanon
personal or family history of thrombosis or thromboembolic disorders
hepatic tumors or active liver disease
known or suspected carcinoma of the breast or history of breast cancer
more that one cardiovascular risk factor such as hypertension or diabetes
present use or use within 2 months of device insertion of a CYP3A4 inducer
breastfeeding women
use of an investigational drug within 2 months of device insertion
use of injectable contraception within 6 months of device insertion
planning a pregnancy in the next 12 months
known HIV infection
smoking over the age of 35
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
45 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: University of Chicago
Authority: United States: Institutional Review Board
Locations
-
University of Chicago
Chicago
Illinois
60637
United States
Officials
Melissa Gilliam, MD, MPH (Principal Investigator, University of Chicago)
Sara J Mornar, DO (Study Director, University of Chicago)
Sponsors
University of Chicago (Lead Sponsor)
University of Washington (Collaborator)
References
None.
Links
- Date Verified
- February 1st, 2012
- First Received
- February 4th, 2012
- Last Changed
- February 4th, 2012
Information obtained from ClinicalTrials.gov on February 06, 2012. Link to the current ClinicalTrials.gov record.
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