Oral Contraceptive Pill (OCP) Pharmacogenomics

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Yale University
Study ID
NCT06334315
Phase
PHASE4
Status
Recruiting
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Conditions

  • Contraception
  • Pharmacogenomic Drug Interaction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Desogestrel / Ethinyl Estradiol Pill — DRUG
    Standard pill packs containing 21 active pills and 7 placebo pills

Study Details

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)

Key Dates

Start date
Oct 29, 2024
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
700 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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)

Primary Outcome Measure

Serum etonogestrel concentration [ Time Frame: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Yale UniversityNew HavenConnecticut06520
AmberJean Hansen
[email protected]
203-737-7962
Aaron Lazorwitz, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical Campus· Aurora, COYale University· New Haven, CT

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