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RECRUITING

NCT06334315

PHASE4

Oral Contraceptive Pill (OCP) Pharmacogenomics

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

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)

Official title: Influence of Genetics Variants on the Pharmacokinetics and Pharmacodynamics of Combined Oral Contraceptive Pill Users

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2024-10-29

Completion Date

2028-05

Last Updated

2025-08-22

Healthy Volunteers

Yes

Conditions

Contraception Pharmacogenomic Drug Interaction

Interventions

DRUG

Desogestrel / Ethinyl Estradiol Pill

Standard pill packs containing 21 active pills and 7 placebo pills

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Female, aged 18-45 years old 4. 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. 5. Ability to take oral medication and be willing to adhere to the oral contraceptive pill (DSG/EE) regimen 6. Body-mass index ≥18.5kg/m2 7. Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study 8. Normal blood pressure measurement at study screening 9. Negative urine pregnancy test at study screening Exclusion Criteria: 1. Currently taking any known CYP3A inducers/inhibitors (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort)43 2. Any medical conditions that affect liver function (e.g., hepatitis, cirrhosis) 3. Contraindications to estrogen-containing contraception (based on category 3 or 4 recommendations in the CDC MEC guidelines42) 1. Current breast cancer or personal history of breast cancer 2. Severe decompensated cirrhosis 3. Personal history of deep venous thrombosis or pulmonary embolism 4. Recent major surgery with prolonged immobilization 5. Diabetes with nephropathy, retinopathy, neuropathy, or other vascular disease 6. Current gallbladder disease 7. Migraine headaches with aura 8. History of malabsorptive bariatric surgery 9. History of cholestasis due to past oral contraceptive pill use 10. Personal history of hypertension 11. Personal history of ischemic heart disease 12. Known thrombogenic mutations 13. Personal history of focal nodular hyperplasia of the liver, hepatocellular adenoma, or malignant hepatoma 14. Multiple sclerosis with prolonged immobility 15. History of peripartum cardiomyopathy 16. Current tobacco smoker and age ≥35 years 17. History of complicated solid organ transplantation 18. Personal history of stroke 19. Personal history of superficial venous thrombosis 20. Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies 21. Complicated valvular heart disease 22. Current use of fosamprenavir or lamotrigine 4. Use of injectable contraceptive method within 6 months or current use of an ENG implant 5. Childbirth within 6 months

Locations (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States