Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104609
• Other study ID #: HS-12-00602
• Status: Completed
• Start date: April 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Obesity

Intervention

Drug:
• Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax)		Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Secondary	Time to maximum concentration (Tmax)		0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Secondary	Minimum concentration (Cmin)		Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Secondary	Area under the concentration time-curve (AUC)		Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs