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Oral Contraceptive Pill (OCP) Pharmacogenomics

StatusRecruiting
PhasePhase 4
Started2024-10-29
View on ClinicalTrials.gov ↗

Amendment history

2026-07-14
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 2 sites
2025-08-21
minor
Study Status v5
Re-verified, no change to tracked fields
2024-11-13
minor
Study Status v4
Start date2024-10-24→2024-10-29
2024-11-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10→confirmed 2024-10-24
Study sites2 entries, revised
Yale University
2024-09-06
minor
Study Status v2
Start date2024-07→2024-10
2024-05-20
minor
Study Status, Study Description v1
Start date2024-05→2024-07
2024-03-20
minor
Original filing
487 trials monitored
See 35 trials at risk
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)
Trial Details
NCT Number NCT06334315
Lead Sponsor Yale University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Contraception, Pharmacogenomic Drug Interaction
Enrollment 700 participants
Start Date 2024-10-29
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-16