RECRUITING

Oral Contraceptive Pill (OCP) Pharmacogenomics

Conditions

Contraception Pharmacogenomic Drug Interaction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-10-29

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06334315

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Aaron M Lazorwitz, MD, PhD

CONTACT

2037854688

aaron.lazorwitz@yale.edu

Principal Investigator

Aaron M Lazorwitz, MD, PhD

PRINCIPAL_INVESTIGATOR

Yale School of Medicine

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Yale University

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Aaron M Lazorwitz, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29

Study Completion Date2028-05

Study Record Updates

Study Start Date2024-10-29

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

Contraception
Pharmacogenomic Drug Interaction