NCT00724438|Completed
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Sponsor study identifier
observational
18
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 25, 2008
Actual (reported)July 29, 2008
Actual (reported)August 2009
Actual (reported)December 2011
Actual (reported)To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.
6 months
To describe ease of insertion and palpation of Implanon among obese women
6 months
To describe bleeding patterns among obese users of Implanon
6 months
To describe the acceptability of Implanon among obese women
6 months
To describe the discontinuation rates, reason for discontinuation, and ease of removal in obese women who discontinue the device before or at the end of the 6 month study period
6 months
To determine whether etonogestrel levels can be obtained from finger-stick blood spots
6 months
Obese women: women with a body mass index (BMI) \>30
Normal weight women: women with a BMI \<25
Participants will be recruited from resident and faculty practices at the University of Chicago outpatient facilities and from the University of Chicago clinical trails database of past study participants.
University of Chicago
Chicago, Illinois, 60637, United States
whole blood, serum, plasma
Melissa Gilliam, MD, MPH
University of Chicago
Sara J Mornar, DO
University of Chicago
18 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
US Ovulation Inhibition Study in Obese Women
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
September 5, 2013
Record last verified: 2013-09
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