Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics
NCT ID: NCT03092037
Last Updated: 2022-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
900 participants
OBSERVATIONAL
2017-03-23
2022-04-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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All participants
All participants will have their blood drawn. DNA will be extracted from whole blood, and serum will be analyzed for ENG concentrations. Genotyping data will be analyzed for associations with serum ENG concentrations.
Blood draw
The Investigators will collect serum and whole blood from participants.
All participants (side-effects)
All participants will have their blood drawn and complete a brief questionnaire regarding bleeding patterns and side-effects. DNA will be extracted from whole blood and genotyping data will be analyzed for associations with specific bleeding patterns and side-effects.
Blood draw
The Investigators will collect serum and whole blood from participants.
Interventions
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Blood draw
The Investigators will collect serum and whole blood from participants.
Eligibility Criteria
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Inclusion Criteria
* have had an ENG contraceptive implant in place for 12-36 months
Exclusion Criteria
* Medical conditions that could impact baseline liver function (e.g. hepatitis, cirrhosis)
* Body mass index (BMI) less than 18.5
18 Years
45 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Aaron Lazorwitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver
Aurora, Colorado, United States
Countries
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References
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Lazorwitz A, Aquilante CL, Shortt JA, Gignoux CR, Teal S, Sheeder J. Pharmacogenomics of the Etonogestrel Contraceptive Implant: A Genome-Wide Association Study of Steady-State Etonogestrel Concentrations. O G Open. 2025 Feb 27;2(1):e066. doi: 10.1097/og9.0000000000000066. eCollection 2025 Feb.
Lazorwitz A, Sheeder J, Teal S. The influence of lifestyle factors on serum etonogestrel concentrations among contraceptive implant users. Contraception. 2024 Dec;140:110539. doi: 10.1016/j.contraception.2024.110539. Epub 2024 Jul 11.
Lazorwitz A, Sheeder J, Teal S. Variability in repeat serum etonogestrel concentrations among contraceptive implant users during the steady-release pharmacokinetic period. Contraception. 2022 Apr;108:65-68. doi: 10.1016/j.contraception.2021.12.008. Epub 2021 Dec 29.
Lazorwitz A, Aquilante CL, Shortt JA, Sheeder J, Teal S, Gignoux CR. Applicability of ancestral genotyping in pharmacogenomic research with hormonal contraception. Clin Transl Sci. 2021 Sep;14(5):1713-1718. doi: 10.1111/cts.13014. Epub 2021 May 2.
Lazorwitz A, Sheeder J, Teal S. An exploratory study on the association of lifestyle factors with serum etonogestrel concentrations among contraceptive implant users. Eur J Contracept Reprod Health Care. 2021 Aug;26(4):323-325. doi: 10.1080/13625187.2021.1887475. Epub 2021 Feb 17.
Lazorwitz A, Aquilante CL, Sheeder J, Guiahi M, Teal S. Relationship between patient characteristics and serum etonogestrel concentrations in contraceptive implant users. Contraception. 2019 Jul;100(1):37-41. doi: 10.1016/j.contraception.2019.03.045. Epub 2019 Apr 10.
Lazorwitz A, Aquilante CL, Oreschak K, Sheeder J, Guiahi M, Teal S. Influence of Genetic Variants on Steady-State Etonogestrel Concentrations Among Contraceptive Implant Users. Obstet Gynecol. 2019 Apr;133(4):783-794. doi: 10.1097/AOG.0000000000003189.
Other Identifiers
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16-2462
Identifier Type: -
Identifier Source: org_study_id
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