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Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT03092037
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of Colorado, Denver

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
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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort 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.




Primary Outcome Measures :
  1. 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

  2. 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.


Biospecimen Retention:   Samples With DNA
Whole blood samples will be collected at the enrollment visit and will undergo DNA extraction using commercial Qiagen® kits in Dr. Christina Aquilante's laboratory.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligible participants must be females as we are studying the ENG contraceptive implant.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will enroll 700 women of reproductive age (18-45 years) who have had an ENG contraceptive implant in place for 12-36 months.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092037


Contacts
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Contact: Rebecca Seale 303-724-2013 rebecca.seale@ucdenver.edu
Contact: Lisa Powers 303-724-5284 lisa.powers@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Lisa Powers       lisa.powers@ucdenver.edu   
Contact: Rebecca Seale       Rebecca.Seale@ucdenver.edu   
Principal Investigator: Aaron Lazorwitz, MD         
Sponsors and Collaborators
University of Colorado, Denver
Society of Family Planning
Investigators
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Principal Investigator: Aaron Lazorwitz, MD University of Colorado, Denver

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03092037     History of Changes
Other Study ID Numbers: 16-2462
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Etonogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs