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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Obese women: women with a body mass index (BMI) >30 | ||
| 2 | Normal weight women: women with a BMI <25 |
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| Measure | Description | Time Frame |
|---|---|---|
| To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To describe ease of insertion and palpation of Implanon among obese women | 6 months | |
| To describe bleeding patterns among obese users of Implanon | 6 months | |
| To describe the acceptability of Implanon among obese women |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Gilliam, MD, MPH | University of Chicago | Principal Investigator |
| Sara J Mornar, DO | University of Chicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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whole blood, serum, plasma
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |