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 participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Female, aged 18-45 years old
✓. In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories.
✓. Ability to take oral medication and be willing to adhere to the oral contraceptive pill (DSG/EE) regimen
✓. Body-mass index ≥18.5kg/m2
✓. Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study
✓. Normal blood pressure measurement at study screening
Exclusion criteria
What they're measuring
1
Serum etonogestrel concentration
Timeframe: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days)
2
Serum ethinyl estradiol concentration
Timeframe: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days)