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Progesterone Receptor Modulator

Ulipristal Acetate for Emergency Birth Control

Phase 4
Recruiting
Led By ALISON EDELMAN, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 1 menstrual cycle (assessed up to approximately 30 days)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial wants to study if genetic factors affect the success of emergency contraception and why some people have higher risk of failure.

Who is the study for?
This trial is for generally healthy women aged 18-40 with regular menstrual cycles, who are not pregnant, seeking pregnancy, or breastfeeding. Participants should have no known allergy to the study medication and must not be using certain drugs that affect its metabolism.
What is being tested?
The study investigates why emergency contraceptives like Ulipristal acetate work for some but fail for others. It's looking into whether genetic differences influence how well these contraceptives prevent pregnancy after unprotected sex.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with Ulipristal acetate may include headache, nausea, abdominal pain, fatigue and dizziness. Each individual might experience side effects differently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 1 menstrual cycle (assessed up to approximately 30 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 1 menstrual cycle (assessed up to approximately 30 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of UPA
Delay in follicular rupture

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Active CYP3A5 AlleleActive Control1 Intervention
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles
Group II: Inactive CYP3A5 AlleleActive Control1 Intervention
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,169 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,567 Total Patients Enrolled
ALISON EDELMAN, MDPrincipal InvestigatorOregon Health and Science University

Media Library

Ulipristal acetate (Progesterone Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05674513 — Phase 4
Birth Control Research Study Groups: Active CYP3A5 Allele, Inactive CYP3A5 Allele
Birth Control Clinical Trial 2023: Ulipristal acetate Highlights & Side Effects. Trial Name: NCT05674513 — Phase 4
Ulipristal acetate (Progesterone Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674513 — Phase 4
~71 spots leftby Dec 2026
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