Recruiting

OCP Pharmacogenomics

Sponsor:

Yale University

Code:

NCT06334315

Conditions

Contraception

Pharmacogenomic Drug Interaction

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Desogestrel / Ethinyl Estradiol Pill

Study Details

Brief 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)

Conditions

Contraception

Pharmacogenomic Drug Interaction

Study ID

NCT06334315

Start date

Oct 29, 2024

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

700 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combined oral contraceptive pill users

Administered a combined oral contraceptive pill containing desogestrel and ethinyl estradiol (Desogen, 0.15mg desogestrel and 0.03mg ethinyl estradiol per active pill) for at least one cycle (21 days) and up to 13 total cycles (one year)

Interventions

Desogestrel / Ethinyl Estradiol Pill

Standard pill packs containing 21 active pills and 7 placebo pills

Primary outcome measure

  • Serum etonogestrel concentration [ Time Frame: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days) ]
  • Serum ethinyl estradiol concentration [ Time Frame: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

Aaron M Lazorwitz, MD, PhD

2037854688aaron.lazorwitz@yale.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Aaron Lazorwitz, MD, PhD

More Information

Sponsor

Yale University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-16.