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Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Levonorgestrel 1.5mg by mouth once (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Southern California

Overall contact:
M Natavio, Phone: 323-226-3104

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Maximum concentration (Cmax)

Secondary outcome:

Time to maximum concentration (Tmax)

Minimum concentration (Cmin)

Area under the concentration time-curve (AUC)

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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

Locations and Contacts

M Natavio, Phone: 323-226-3104

University of Southern California, Los Angeles, California 90033, United States; Recruiting
Angelica Mora, Phone: 323-226-3104
Melissa Natavio, MD, MPH, Principal Investigator
Additional Information

Starting date: April 2013
Last updated: June 20, 2015

Page last updated: August 23, 2015

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