Oral Contraceptive Pill (OCP) Pharmacogenomics

Last updated: November 13, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

4

Condition

Contraception

Treatment

Desogestrel / Ethinyl Estradiol Pill

Clinical Study ID

NCT06334315
2000037337
R01HD111436
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Female, aged 18-45 years old

  4. In good general health as evidenced by medical history and no need for regularintensive medical interventions (e.g., inpatient admissions, surgical treatments).The Principal Investigator will be responsible for determining good general healthfor potential participants with complicated medical histories.

  5. Ability to take oral medication and be willing to adhere to the oral contraceptivepill (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

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 4recommendations in the CDC MEC guidelines42)

  4. Current breast cancer or personal history of breast cancer

  5. Severe decompensated cirrhosis

  6. Personal history of deep venous thrombosis or pulmonary embolism

  7. Recent major surgery with prolonged immobilization

  8. Diabetes with nephropathy, retinopathy, neuropathy, or other vascular disease

  9. Current gallbladder disease

  10. Migraine headaches with aura

  11. History of malabsorptive bariatric surgery

  12. History of cholestasis due to past oral contraceptive pill use

  13. Personal history of hypertension

  14. Personal history of ischemic heart disease

  15. Known thrombogenic mutations

  16. Personal history of focal nodular hyperplasia of the liver, hepatocellularadenoma, or malignant hepatoma

  17. Multiple sclerosis with prolonged immobility

  18. History of peripartum cardiomyopathy

  19. Current tobacco smoker and age ≥35 years

  20. History of complicated solid organ transplantation

  21. Personal history of stroke

  22. Personal history of superficial venous thrombosis

  23. Systemic lupus erythematosus with positive or unknown antiphospholipidantibodies

  24. Complicated valvular heart disease

  25. Current use of fosamprenavir or lamotrigine

  26. Use of injectable contraceptive method within 6 months or current use of an ENGimplant

  27. Childbirth within 6 months

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: Desogestrel / Ethinyl Estradiol Pill
Phase: 4
Study Start date:
October 29, 2024
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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