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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03092037
Other study ID # 16-2462
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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