Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

Contraception Clinical Trial

Official title:

Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092037
• Other study ID #: 16-2462
• Status: Completed
• Start date: March 23, 2017
• Est. completion date: April 29, 2022

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Blood draw
The Investigators will collect serum and whole blood from participants.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of genetic variants in cases versus controls	Genetic variants will be analyzed using a Taqman microarray chip for 120 pre-selected variants	DNA extracted from whole blood specimens will be genotyped at the conclusion of enrollment, approximately 12 months.
Primary	Genome wide genotyping results	Participants will undergo genotyping using a custom MEGA chip at the Colorado Center for Personalized Medicine. Imputation of the chip results will be performed.	DNA extracted from whole blood specimens will be genotyped at the conclusion of enrollment, approximately 15 months.