RecruitingPhase 4

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

United States140 participantsStarted 2023-01-09

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delay in follicular rupture

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

Concentration of UPA

Timeframe: 5 days after taking study drug

Trial details

NCT IDNCT05674513

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Women's Health Research Unit Department of OB/GYN

503-494-3666 whru@ohsu.edu

View on ClinicalTrials.gov More Contraceptive Usage trials