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NCT06334315 · ClinicalTrials.gov registry record · Phase 4
Oral Contraceptive Pill (OCP) Pharmacogenomics
A Phase 4 study of Contraception and Pharmacogenomic Drug Interaction, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 700
- Enrollment target
- 2
- Study locations
NCT06334315 is a Phase 4 study of Contraception and Pharmacogenomic Drug Interaction that is actively recruiting participants, run by Yale University. The registered enrollment target is 700 participants, above the 445-participant average among 72 other Contraception trials with a reported enrollment target (57% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT06334315, a Phase 4 study of Contraception and Pharmacogenomic Drug Interaction, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 700 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- DRUG Desogestrel / Ethinyl Estradiol Pill
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2028-05 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06334315
The ClinicalTrials.gov registry entry for NCT06334315 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 72 other Contraception trials with a reported enrollment target (57% higher). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Desogestrel / Ethinyl Estradiol Pill is the first listed.
NCT06334315 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06334315 about?
NCT06334315 is a clinical study titled "Oral Contraceptive Pill (OCP) Pharmacogenomics". 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 al...
What is the current status of trial NCT06334315?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 700 participants. The study started on 2024-10-29. Estimated completion is 2028-05.
What conditions does trial NCT06334315 study?
This clinical trial studies the following conditions: Contraception, Pharmacogenomic Drug Interaction.
What interventions are being tested in trial NCT06334315?
The interventions under investigation include: Desogestrel / Ethinyl Estradiol Pill (DRUG).
Who is sponsoring clinical trial NCT06334315?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06334315 being conducted?
This trial has 2 study locations across Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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