Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

The proposed study will investigate the relationship between genetic variants and serum contraceptive hormone levels, specifically the progestin etonogestrel. This study will provide the foundation for future pharmacogenomic investigations of more commonly used contraceptive methods with higher failure rates.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

The Investigators will collect serum and whole blood from participants.

Primary outcomes

Proportion of genetic variants in cases versus controls

Time frame: DNA extracted from whole blood specimens will be genotyped at the conclusion of enrollment, approximately 12 months.

Genetic variants will be analyzed using a Taqman microarray chip for 120 pre-selected variants
Genome wide genotyping results

Time frame: DNA extracted from whole blood specimens will be genotyped at the conclusion of enrollment, approximately 15 months.

Participants will undergo genotyping using a custom MEGA chip at the Colorado Center for Personalized Medicine. Imputation of the chip results will be performed.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Society of Family Planning

Registry information

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Mar 27, 2017
Registry last updated: Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed