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: 1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women affect the primary mechanism of action, which is inhibition of ovulation. 2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free LNG.
Study Type
OBSERVATIONAL
Enrollment
26
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
University of Southern California
Los Angeles, California, United States
Maximum concentration (Cmax)
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Time to maximum concentration (Tmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Minimum concentration (Cmin)
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Area under the concentration time-curve (AUC)
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs
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