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Oral Contraceptive Pill (OCP) Pharmacogenomics

NCT06334315 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

DRUG

Desogestrel / Ethinyl Estradiol Pill

Standard pill packs containing 21 active pills and 7 placebo pills

Sponsors & Collaborators

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

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Aaron M Lazorwitz, MD, PhD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06334315 on ClinicalTrials.gov