Clinical trial NCT00724438: Pharmacokinetics of Implanon in Obese Women
Official title: Pharmacokinetics of Implanon in Obese Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Obesity
Keywords: Contraception
Implanon
Obesity
Blood spots
Implant
Pharmacokinetics
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2008-07-29
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.
timeFrame: 6 months
Secondary outcomes:
measure: To describe ease of insertion and palpation of Implanon among obese women
timeFrame: 6 months
measure: To describe bleeding patterns among obese users of Implanon
timeFrame: 6 months
measure: To describe the acceptability of Implanon among obese women
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: To determine whether etonogestrel levels can be obtained from finger-stick blood spots
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Melissa Gilliam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Sara J Mornar, DO
role: STUDY_DIRECTOR
References: