NCT02104609

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

March 25, 2014

Last Update Submit

April 16, 2019

Conditions

Obesity

Keywords

ObesityEmergency contraceptionLevonorgestrel emergency contraception

Outcome Measures

Primary Outcomes (1)

  • Maximum concentration (Cmax)

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

Secondary Outcomes (3)

  • Time to maximum concentration (Tmax)

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

  • Minimum concentration (Cmin)

    Time 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

Study Arms (3)

Normal weight women

Levonorgestrel 1.5mg by mouth once

Drug: Levonorgestrel 1.5mg by mouth once

Obese women

Levonorgestrel 1.5mg by mouth once

Drug: Levonorgestrel 1.5mg by mouth once

Extremely obese women

Levonorgestrel 1.5mg by mouth once

Drug: Levonorgestrel 1.5mg by mouth once

Interventions

Levonorgestrel 1.5mg by mouth onceDRUG

Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8

Also known as: Plan B One Step, Next Choice One Dose
Extremely obese womenNormal weight womenObese women

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Non-smoking women between ages 18-35 years with regular menstrual cycles (24-35 days) will be enrolled, to include 10 normal weight (BMI = 18.5-24.9 kg/m2) women, 10 obese (BMI = 30-39.9 kg/m2) and 10 extremely obese (BMI ≥ 40 kg/m2) women

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • M Natavio

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Professor

Study Record Dates

First Submitted

March 25, 2014

First Posted

April 4, 2014

Study Start

April 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(1)