Pharmacokinetics of Implanon in Obese Women
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
University of Washington
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier:
NCT00724438
First received: July 25, 2008
Last updated: September 25, 2012
Last verified: September 2012
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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: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacokinetics of Implanon in Obese Women |
Resource links provided by NLM:
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
whole blood, serum, plasma
| Enrollment: | 18 |
| Study Start Date: | July 2008 |
| Study Completion Date: | December 2011 |
| 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
Locations
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Melissa Gilliam, Chief, Section of Family Planning & Contraceptive Research, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00724438 History of Changes |
| Other Study ID Numbers: | 15956A |
| Study First Received: | July 25, 2008 |
| Last Updated: | September 25, 2012 |
| 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 Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms 3-keto-desogestrel |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013