Obesity
Conditions
Keywords
Obesity, Emergency contraception, Levonorgestrel emergency contraception
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.
Interventions
DRUGLevonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Sponsors
Society of Family Planning
University of Southern California
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed