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Clinical trialNCT06334315RecruitingPhase 4Interventional

Oral Contraceptive Pill (OCP) Pharmacogenomics

SponsorYale UniversityEnrollment700ContraceptionPharmacogenomic Drug Interaction
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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)

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, United States

    Recruiting
  • Yale University

    New Haven, Connecticut, United States

    Aaron Lazorwitz, MD, PhD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Desogestrel
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Oct 2024
Primary completion
31 May 2028
Completion
31 May 2028
Last update posted
16 Jul 2026
Registered enrollment
700
Registry id
NCT06334315

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.