Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

Completed

• Conditions: Obesity
• Interventions: Drug: Levonorgestrel 1.5mg by mouth once

• Registration Number: NCT02104609
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Women between ages 18-35 years

  • Regular menstrual cycles (24-35 days) for the past 2 months
  • Ovulatory at defined by midluteal progesterone level >3 ng/mL (Day 18-25)
  • Belongs to one of the following categories: normal weight (BMI = 18.5-24.9 kg/m2), obese (BMI = 30-39.9 kg/m2) or extremely obese (BMI ≥ 40 kg/m2)
  • Participant has no intention of or desire to conceive (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study
  • Participant agrees to consistently use an effective method of nonhormonal contraception throughout the duration of study, which could include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, non-hormonal intra-uterine devise (IUD), or sterilization.
  • Able to give informed consent

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Exclusion Criteria

• • Known renal or liver disease

  • Known pituitary disorder
  • Known adrenal disorder
  • Known thyroid disorder
  • Use of medication known to alter the cytochrome P450 system
  • Use of depot-medroxyprogesterone acetate in the previous 6 months or any other hormonal contraceptive in the previous 3 months
  • Currently breastfeeding
  • Pregnant
  • Pregnancy in the prior month
  • Known allergy to medication
  • Other specific contraindications to LNG EC

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese women	Levonorgestrel 1.5mg by mouth once	Levonorgestrel 1.5mg by mouth once
Extremely obese women	Levonorgestrel 1.5mg by mouth once	Levonorgestrel 1.5mg by mouth once
Normal weight women	Levonorgestrel 1.5mg by mouth once	Levonorgestrel 1.5mg by mouth once

Primary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax)	Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours

Secondary Outcome Measures

Name	Time	Method
Minimum concentration (Cmin)	Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Time to maximum concentration (Tmax)	0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Area under the concentration time-curve (AUC)	Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States