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New treatment option for Contraception
Official title Oral Contraceptive Pill (OCP) Pharmacogenomics
ClinicalTrials.gov ID: NCT06334315
What this study is testing
What is Desogestrel / Ethinyl Estradiol Pill?
Desogestrel / Ethinyl Estradiol Pill is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-45 years old
- In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical...
- Ability to take oral medication and be willing to adhere to the oral contraceptive pill (DSG/EE) regimen
You likely can't join if
- Currently taking any known CYP3A inducers/inhibitors (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort)43
- Any medical conditions that affect liver function (e.g., hepatitis, cirrhosis)
- Contraindications to estrogen-containing contraception (based on category 3 or 4 recommendations in the CDC MEC guidelines42)
- Current breast cancer or personal history of breast cancer
- Severe decompensated cirrhosis
- Personal history of deep venous thrombosis or pulmonary embolism
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-45 years old
- 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...
- Ability to take oral medication and be willing to adhere to the oral contraceptive pill (DSG/EE) regimen
- Body-mass index ≥18.5kg/m2
- Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study
- Normal blood pressure measurement at study screening
- Negative urine pregnancy test at study screening
- Currently taking any known CYP3A inducers/inhibitors (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort)43
- Any medical conditions that affect liver function (e.g., hepatitis, cirrhosis)
- Contraindications to estrogen-containing contraception (based on category 3 or 4 recommendations in the CDC MEC guidelines42)
- Current breast cancer or personal history of breast cancer
- Severe decompensated cirrhosis
- Personal history of deep venous thrombosis or pulmonary embolism
- Recent major surgery with prolonged immobilization
- Diabetes with nephropathy, retinopathy, neuropathy, or other vascular disease
- Current gallbladder disease
- Migraine headaches with aura
- History of malabsorptive bariatric surgery
- History of cholestasis due to past oral contraceptive pill use
- Personal history of hypertension
- Personal history of ischemic heart disease
- Known thrombogenic mutations
- Personal history of focal nodular hyperplasia of the liver, hepatocellular adenoma, or malignant hepatoma
- Multiple sclerosis with prolonged immobility
- History of peripartum cardiomyopathy
- Current tobacco smoker and age ≥35 years
- History of complicated solid organ transplantation
- Personal history of stroke
- Personal history of superficial venous thrombosis
- Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
- Complicated valvular heart disease
- Current use of fosamprenavir or lamotrigine
- Use of injectable contraceptive method within 6 months or current use of an ENG implant
- Childbirth within 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.