Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02104609
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2014-03-25
Brief Title:
Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight Obese and Extremely Obese Users a Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None