Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
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.