Actively Recruiting
Oral Contraceptive Pill (OCP) Pharmacogenomics
Led by Yale University · Updated on 2025-08-22
700
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Oral Contraceptive Pill (OCP) Pharmacogenomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the study duration
- Female aged 18 to 45 years old
- In good general health without need for regular intensive medical treatments
- Ability and willingness to take oral contraceptive pill (DSG/EE) as directed
- Body-mass index of 18.5 kg/m2 or higher
- Willing to avoid medications and supplements that affect CYP3A enzyme during the study
- Normal blood pressure at screening
- Negative urine pregnancy test at screening
You will not qualify if you...
- Currently taking medications or supplements known to affect CYP3A enzymes such as rifampin, carbamazepine, ketoconazole, or St. John's wort
- Medical conditions affecting liver function like hepatitis or cirrhosis
- Contraindications to estrogen-containing contraception including:
- Current or past breast cancer
- Severe liver cirrhosis
- History of blood clots or major recent surgery with immobilization
- Diabetes with vascular complications
- Gallbladder disease
- Migraines with aura
- History of bariatric surgery affecting absorption
- Past cholestasis from oral contraceptives
- History of hypertension or ischemic heart disease
- Known blood clotting mutations
- Liver tumors or cancer
- Multiple sclerosis with immobility
- Peripartum cardiomyopathy
- Tobacco use if age 35 or older
- Complicated organ transplantation
- History of stroke or superficial venous thrombosis
- Lupus with positive or unknown antiphospholipid antibodies
- Complex heart valve disease
- Current use of fosamprenavir or lamotrigine
- Use of injectable contraceptives within 6 months or current etonogestrel implant
- Childbirth within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
A
Aaron M Lazorwitz, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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