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RecruitingNCT05674513Updated Jul 9, 2026

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

A Phase 4 interventional study of Ulipristal acetate in Contraceptive Usage, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Oregon Health and Science University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

Read the detailed description

Each of us can respond differently to a drug or medication based on our genetics. An emergency contraceptive, ulipristal acetate or UPA, normally works by stopping or delaying the ovary from releasing an egg (ovulation). Our bodies break down UPA in order to use it through a system call the cytochrome P450 pathway but this pathway can be faster or slower depending on our genetics. The investigators want to learn more about how our individual genetic differences in this pathway change how the ovary responds to UPA. The overall goal of this research is to improve the effectiveness of emergency contraception for all people.

02

Conditions studied

  • Contraceptive Usage

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Keywords

  • Ulipristal acetate
  • Emergency contraception
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Generally healthy women
  • Aged 18-40
  • regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng/mL or greater during the luteal phase of the screening cycle.

Exclusion criteria

Exclusion Criteria:

  • Pregnant, seeking pregnancy, or breastfeeding
  • Known allergy to study medication
  • Recent use of hormonal contraception
  • Irregular periods (\<21 days or >35 day cycles)
  • Routine use of nonsteroidal anti-inflammatory drugs
  • Metabolic disorders
  • Smoking
  • Any condition that would preclude the provision of informed consent
  • Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be CYP3A4 inducers, inhibitors, or CYP3A drug substrates
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Active CYP3A5 Allele

    Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles

    Drug: Ulipristal acetate

  • Active comparator
    Inactive CYP3A5 Allele

    Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles

    Drug: Ulipristal acetate

Interventions

  • DrugUlipristal acetate

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

05

What researchers measure

Primary outcomes

  1. Delay in follicular rupture

    Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or \>50% reduction in size of the leading follicle

    Time frame: over 1 menstrual cycle (assessed up to approximately 30 days)

  2. Concentration of UPA

    mean concentration maximum (Cmax) for UPA

    Time frame: 5 days after taking study drug

06

Study locations

1 of 1 sites recruiting
  • OHSU
    Portland, Oregon 97239, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT05674513
Lead sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Alison Edelman (Professor, OB/GYN, Oregon Health and Science University) — Principal investigator
First posted
Jan 6, 2023
Start date
Jan 9, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 9, 2026

Study contacts

Women's Health Research Unit Department of OB/GYN
Contact
whru@ohsu.edu
503-494-3666
ALISON EDELMAN, MD
principal investigator · Oregon Health and Science University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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