Oral Contraceptive Pill (OCP) Pharmacogenomics

NCT ID: NCT06334315

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2028-05-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Desogestrel / Ethinyl Estradiol Pill

Intervention Type: DRUG

Standard pill packs containing 21 active pills and 7 placebo pills

Interventions

Desogestrel / Ethinyl Estradiol Pill

Standard pill packs containing 21 active pills and 7 placebo pills

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron M Lazorwitz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: NOT_YET_RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aaron M Lazorwitz, MD, PhD

Role: CONTACT

aaron.lazorwitz@yale.edu

2037854688

Facility Contacts

AmberJean Hansen

Role: primary

BirthControlGene@yale.edu

203-737-7962

Other Identifiers

R01HD111436

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000037337

Identifier Type: -

Identifier Source: org_study_id