Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT03092037

Collaborator

Society of Family Planning (Other)

900

Enrollment

Location

61.2

Actual Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Procedure: Blood draw

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

900 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

Actual Study Start Date :

Mar 23, 2017

Actual Primary Completion Date :

Apr 29, 2022

Actual Study Completion Date :

Apr 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: 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.	Procedure: Blood draw The Investigators will collect serum and whole blood from participants.

Arm

Intervention/Treatment

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.

Procedure: 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.

Procedure: Blood draw

The Investigators will collect serum and whole blood from participants.

Outcome Measures

Primary Outcome Measures

Proportion of genetic variants in cases versus controls [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver
Society of Family Planning

Investigators

Principal Investigator: Aaron Lazorwitz, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT03092037

Other Study ID Numbers:

16-2462

First Posted:

Mar 27, 2017

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 16, 2022