NCT05674513 Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
| NCT ID | NCT05674513 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oregon Health and Science University |
| Condition | Contraceptive Usage |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-01-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2023-01-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
ALISON EDELMAN, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT05674513 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Contraceptive Usage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05674513 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05674513 currently recruiting?
Yes, NCT05674513 is actively recruiting participants. Contact the research team at whru@ohsu.edu for enrollment information.
Where is the NCT05674513 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05674513 clinical trial?
NCT05674513 is sponsored by Oregon Health and Science University. The principal investigator is ALISON EDELMAN, MD at Oregon Health and Science University. The trial plans to enroll 140 participants.