Status:
COMPLETED
Pharmacokinetics of Implanon in Obese Women
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
University of Washington
Conditions:
Contraception
Obesity
Eligibility:
FEMALE
18-45 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00724438
Start Date
July 1 2008
End Date
December 1 2011
Last Update
September 5 2013
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637