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Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

NCT02104609 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2019-04-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

Levonorgestrel 1.5mg by mouth once

Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8

Sponsors & Collaborators

Principal Investigators

  • M Natavio · University of Southern California

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104609 on ClinicalTrials.gov