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Pharmacokinetics of Implanon in Obese Women

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ClinicalTrials.gov Identifier: NCT00724438
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : September 5, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

July 25, 2008
July 29, 2008
September 5, 2013
July 2008
August 2009   (Final data collection date for primary outcome measure)
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00724438 on ClinicalTrials.gov Archive Site
  • To describe ease of insertion and palpation of Implanon among obese women [ Time Frame: 6 months ]
  • To describe bleeding patterns among obese users of Implanon [ Time Frame: 6 months ]
  • To describe the acceptability of Implanon among obese women [ Time Frame: 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 [ Time Frame: 6 months ]
  • To determine whether etonogestrel levels can be obtained from finger-stick blood spots [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Implanon in Obese Women
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum, plasma
Non-Probability Sample
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.
  • Contraception
  • Obesity
Not Provided
  • 1
    Obese women: women with a body mass index (BMI) >30
  • 2
    Normal weight women: women with a BMI <25
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2011
August 2009   (Final data collection date for primary outcome measure)

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
  • hemophilia
  • 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
  • known history of PCOS, diabetes, or glucose abnormality
  • 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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00724438
15956A
No
Not Provided
Not Provided
University of Chicago
University of Chicago
University of Washington
Principal Investigator: Melissa Gilliam, MD, MPH University of Chicago
Study Director: Sara J Mornar, DO University of Chicago
University of Chicago
September 2013