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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The purpose of this study is to determine the effects of obesity on the pharmacokinetics of the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of ovulation
Primary hypothesis:
1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution of LNG.
Secondary hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight women | Levonorgestrel 1.5mg by mouth once |
| |
| Obese women | Levonorgestrel 1.5mg by mouth once |
| |
| Extremely obese women | Levonorgestrel 1.5mg by mouth once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel 1.5mg by mouth once | Drug | Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours | |
| Minimum concentration (Cmin) | Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours | |
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Inclusion Criteria:
Women between ages 18-35 years
Exclusion Criteria:
• Known renal or liver disease
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Non-smoking women between ages 18-35 years with regular menstrual cycles (24-35 days) will be enrolled, to include 10 normal weight (BMI = 18.5-24.9 kg/m2) women, 10 obese (BMI = 30-39.9 kg/m2) and 10 extremely obese (BMI ≥ 40 kg/m2) women
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| Name | Affiliation | Role |
|---|---|---|
| M Natavio | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | 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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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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|
| Area under the concentration time-curve (AUC) |
| Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |