ClinicalTrials.gg
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

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
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

Keywords

  • Ulipristal acetate
  • Emergency contraception
03

In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's planned enrollment of 140 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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
  • Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be inducers, inhibitors, or CYP3A drug substrates
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

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

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

06

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05674513
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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Studies of the drug tested here: Ulipristal acetate

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