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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02104609
Study type Observational [Patient Registry]
Source University of Southern California
Contact
Status Completed
Phase
Start date April 2013
Completion date May 2016

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