Pharmacokinetics of Implanon in Obese Women - Full Text View

Sponsor:	University of Chicago
Collaborator:	University of Washington
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00724438

Purpose

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.

Condition
Contraception Obesity

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pharmacokinetics of Implanon in Obese Women

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Obesity

Drug Information available for: Etonogestrel

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe ease of insertion and palpation of Implanon among obese women [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To describe bleeding patterns among obese users of Implanon [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To describe the acceptability of Implanon among obese women [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To determine whether etonogestrel levels can be obtained from finger-stick blood spots [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood, serum, plasma

Estimated Enrollment:	18
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Obese women: women with a body mass index (BMI) >30
2 Normal weight women: women with a BMI <25

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724438

Contacts

Contact: Amy Neustadt, MPH	773-834-3890	aneustadt@babies.bsd.uchicago.edu
Contact: Melissa Gilliam, MD, MPH	773-834-0840	mgilliam@babies.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Amy B Neustadt, MPH 773-834-3890 aneustadt@babies.bsd.uchicago.edu
Contact: Melissa L Gilliam, MD, MPH 773-834-0840 mgilliam@babies.bsd.uchicago.edu

Sponsors and Collaborators

University of Chicago

University of Washington

Investigators

Principal Investigator:	Melissa Gilliam, MD, MPH	University of Chicago
Study Director:	Sara J Mornar, DO	University of Chicago
Study Director:	Amy Neustadt, MPH	University of Chicago

More Information

Additional Information:

University of Chicago Section of Family Planning and Contraceptive Research This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Chicago ( Melissa Gilliam, MD, MPH )
Study ID Numbers:	15956A
Study First Received:	July 25, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00724438 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Contraception
Implanon
Obesity

Blood spots
Implant
Pharmacokinetics

Additional relevant MeSH terms:

Obesity
Contraceptive Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Overweight
Reproductive Control Agents
Pharmacologic Actions

Body Weight
Signs and Symptoms
Therapeutic Uses
Nutrition Disorders
Overnutrition
3-keto-desogestrel

ClinicalTrials.gov processed this record on November 05, 2009