Oral Contraceptive Pill (OCP) Pharmacogenomics (NCT06334315)
Influence of Genetics Variants on the Pharmacokinetics and Pharmacodynamics of Combined Oral Contraceptive Pill Users
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are: * Do individuals with the CYP3A7\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill? * Do individuals with the CYP3A7\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill? * What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users? Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures: * Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill * Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill * Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill * A transvaginal ultrasound to measure any ovarian follicles (optional procedure)
Who can join: Review the eligibility criteria below.
Location: University of Colorado Anschutz Medical Campus โ Aurora, Colorado
Age range: 18 Years to 45 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- University of Colorado Anschutz Medical Campus โ Aurora, Colorado
- Yale University โ New Haven, Connecticut
๐ Contact the Study Coordinator
Phone: (203) 785-4688
Email: aaron.lazorwitz@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Contraception
- Casea S Contraceptive Implants (Casea S) Trial โ Santo Domingo, DN
- Family Planning Elevated: Initiative Evaluation โ Salt Lake City, Utah
- Birth Control to Improve Birth Spacing โ Boston, Massachusetts
- FemBlocยฎ Permanent Contraception - Confirmation Feasibility Trial โ Chandler, Arizona
- The Over The Counter Pill National Study โ Portland, Oregon
- Evaluation of the Efficacy, Safety, and Tolerability of LevoCept โ Berkeley, California
Explore by condition: All Contraception clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.