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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | July 25, 2008 | ||||||||||||
| Last Updated Date | March 24, 2009 | ||||||||||||
| Start Date ICMJE | July 2008 | ||||||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00724438 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Pharmacokinetics of Implanon in Obese Women | ||||||||||||
| Official Title ICMJE | Pharmacokinetics of Implanon in Obese Women | ||||||||||||
| Brief 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. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 18 | ||||||||||||
| Estimated Completion Date | February 2010 | ||||||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | 18 Years to 45 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00724438 | ||||||||||||
| Responsible Party | Melissa Gilliam, MD, MPH, University of Chicago | ||||||||||||
| Study ID Numbers ICMJE | 15956A | ||||||||||||
| Study Sponsor ICMJE | University of Chicago | ||||||||||||
| Collaborators ICMJE | University of Washington | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||||||||||
| Verification Date | March 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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