Pharmacokinetics of Implanon in Obese Women

Completed

• Conditions: Contraception; Obesity

• Registration Number: NCT00724438
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Primary Completion: 2009-08
• Study Completion: 2011-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.	6 months

Secondary Outcome Measures

Name	Time	Method
To describe bleeding patterns among obese users of Implanon	6 months
To describe ease of insertion and palpation of Implanon among obese women	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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States