University of Southern California
Los Angeles, California, 90033, United States
NCT Number: NCT02104609
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.
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Notify Me18 year–35 year
Female
Observational
Los Angeles, California, 90033, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Other names: Plan B One Step, Next Choice One Dose
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs
University of Southern California
Other
Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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