Understanding how genetics affect emergency contraception effectiveness
Official title: Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Run by Oregon Health and Science University · NCT05674513 · Data updated 2026-11-12
This study is trying to see if genetic differences affect how well the emergency contraceptive ulipristal acetate works for different people.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | January 9, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT05674513 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are generally healthy women aged 18-40 with regular menstrual cycles.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have irregular menstrual cycles will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the reasons behind varying effectiveness of the emergency contraceptive ulipristal acetate (UPA) among individuals, focusing on genetic differences that may influence drug metabolism. By examining how the cytochrome P450 pathway affects the breakdown of UPA, researchers aim to determine the relationship between genetic variations and ovulation response to the medication. The ultimate goal is to enhance the efficacy of emergency contraception for diverse populations.
Why it matters
Potential benefit: If successful, this research could lead to more effective emergency contraception options tailored to individual genetic profiles.
How similar studies have gone: While the study explores genetic factors in emergency contraception, similar approaches have shown promise in other areas of pharmacogenomics, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ohsu
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Alison Edelman, Md — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Department of OB/GYN
- Email: whru@ohsu.edu
- Phone: 503-494-3666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.