Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Hospital |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 4/2/2016 |
| Start Date: | April 2013 |
| Contact: | M Natavio |
| Phone: | 323-226-3104 |
Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
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.
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.
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
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