Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

Approximately 700 reproductive age women (18-45) with an Etonogestrel (ENG) contraceptive
implant in place for more than 1 year will be enrolled. Participants will undergo a blood
draw for measurement of ENG concentration (serum) and genotyping (whole blood) and complete a
questionnaire regarding their demographics and contraceptive, gynecological, and obstetrical
history. The research investigators will also consent participants for use of their genetic
samples and clinical data in future unspecified research.

The serum samples will be de-identified for ENG analysis, which will be done using a liquid
chromatography-mass spectrometry method. Additional whole blood samples collected at the
enrollment visit will undergo DNA extraction. A candidate gene study was conducted using the
first 350 participants. The research investigators selected 120 genetic variants for 14
target genes involved in progestin metabolism, regulation, and function for this candidate
gene study. A Genome Wide Association Study will be performed using all 700 participants.
Genotyping will be performed using a custom MultiEthnic Global Array chip through the
Colorado Center for Personalized Medicine.

Inclusion Criteria:

- women of reproductive age (18-45 years)

- have had an ENG contraceptive implant in place for 12-36 months

Exclusion Criteria:

- Use of medications or supplements in the past four weeks which could impact serum ENG
levels through inhibition or induction of CYP enzymes (specifically CYP-3A4)

- Medical conditions that could impact baseline liver function (e.g. hepatitis,
cirrhosis)

- Body mass index (BMI) less than 18.5