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Trial record 7 of 405 for:    LEVONORGESTREL

Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104609
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Melissa Natavio, University of Southern California

Tracking Information
First Submitted Date March 25, 2014
First Posted Date April 4, 2014
Last Update Posted Date April 18, 2019
Study Start Date April 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2014)
Maximum concentration (Cmax) [ Time Frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02104609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 1, 2014)
  • Time to maximum concentration (Tmax) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours ]
  • Minimum concentration (Cmin) [ Time Frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours ]
  • Area under the concentration time-curve (AUC) [ Time Frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
Official Title Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Probability 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
Condition Obesity
Intervention Drug: Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Other Names:
  • Plan B One Step
  • Next Choice One Dose
Study Groups/Cohorts
  • Normal weight women
    Levonorgestrel 1.5mg by mouth once
    Intervention: Drug: Levonorgestrel 1.5mg by mouth once
  • Obese women
    Levonorgestrel 1.5mg by mouth once
    Intervention: Drug: Levonorgestrel 1.5mg by mouth once
  • Extremely obese women
    Levonorgestrel 1.5mg by mouth once
    Intervention: Drug: Levonorgestrel 1.5mg by mouth once
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 16, 2019)
26
Original Estimated Enrollment
 (submitted: April 1, 2014)
30
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02104609
Other Study ID Numbers HS-12-00602
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Melissa Natavio, University of Southern California
Study Sponsor University of Southern California
Collaborators Society of Family Planning
Investigators
Principal Investigator: M Natavio University of Southern California
PRS Account University of Southern California
Verification Date April 2019