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Trial record 7 of 404 for:    LEVONORGESTREL

Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

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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

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.

Condition or disease Intervention/treatment
Obesity Drug: Levonorgestrel 1.5mg by mouth once

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Study Type : Observational [Patient Registry]
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
Study Start Date : April 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
Normal weight women
Levonorgestrel 1.5mg by mouth once
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

Obese women
Levonorgestrel 1.5mg by mouth once
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

Extremely obese women
Levonorgestrel 1.5mg by mouth once
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




Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104609


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Society of Family Planning
Investigators
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Principal Investigator: M Natavio University of Southern California

Additional Information:

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Responsible Party: Melissa Natavio, Asst. Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02104609     History of Changes
Other Study ID Numbers: HS-12-00602
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Melissa Natavio, University of Southern California:
Obesity
Emergency contraception
Levonorgestrel emergency contraception
Additional relevant MeSH terms:
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Levonorgestrel
Obesity
Emergencies
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Disease Attributes
Pathologic Processes
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral