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OpenTrials
Completed

NCT Number: NCT02104609

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 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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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Levonorgestrel 1.5mg by mouth once

Drug

Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8

Other names: Plan B One Step, Next Choice One Dose

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours

  2. Minimum concentration (Cmin)

    Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours

  3. Area under the concentration time-curve (AUC)

    Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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