Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05674513
Phase
PHASE4
Status
Recruiting
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Conditions

  • Contraceptive Usage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Ulipristal acetate — DRUG
    Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles

Study Details

The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.

Key Dates

Start date
Jan 9, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active CYP3A5 Allele
    Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles
  • Active Comparator: Inactive CYP3A5 Allele
    Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles

Primary Outcome Measure

Delay in follicular rupture [ Time Frame: over 1 menstrual cycle (assessed up to approximately 30 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSUPortlandOregon97239-

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By research site
OHSU· Portland, OR

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