Your DNA could determine if your birth control works
NCT ID NCT06334315
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study investigates whether genetic differences influence how the body breaks down hormones in combined oral contraceptive pills, potentially affecting their ability to prevent pregnancy and the side effects experienced. Researchers will give participants a specific birth control pill (desogestrel/ethinyl estradiol) and measure hormone levels, ovarian activity, and side effects. The goal is to understand why the same pill can work differently for different people.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combined oral contraceptive pill containing desogestrel and ethinyl estradiol
- What this could lead to
- If successful, this could help personalize birth control prescriptions based on a person's genetics, improving effectiveness and reducing side effects.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly lead to a new drug or cure. Results may not apply to all populations or contraceptive types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Anschutz Medical Campus
RECRUITINGAurora, Colorado, 80045, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
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