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NCT02104609 · ClinicalTrials.gov registry record
Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
A clinical trial, sponsored by University of Southern California.
- Completed
- Registry status
- 26
- Enrollment target
NCT02104609 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 26 participants.
The verdict
NCT02104609 has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG Levonorgestrel 1.5mg by mouth once
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02104609
The ClinicalTrials.gov registry entry for NCT02104609 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel 1.5mg by mouth once is the first listed.
NCT02104609 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02104609 about?
NCT02104609 is a clinical study titled "Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill". 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 v...
What is the current status of trial NCT02104609?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2013-04. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02104609?
The interventions under investigation include: Levonorgestrel 1.5mg by mouth once (DRUG).
Who is sponsoring clinical trial NCT02104609?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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