Trials / Completed
CompletedNCT03092037
Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 900 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Blood draw | The Investigators will collect serum and whole blood from participants. |
Timeline
- Start date
- 2017-03-23
- Primary completion
- 2022-04-29
- Completion
- 2022-04-29
- First posted
- 2017-03-27
- Last updated
- 2022-08-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03092037. Inclusion in this directory is not an endorsement.