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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 1 menstrual cycle (assessed up to approximately 30 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 1 menstrual cycle (assessed up to approximately 30 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of UPA
Delay in follicular rupture
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
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,772 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,657 Total Patients Enrolled
ALISON EDELMAN, MDPrincipal InvestigatorOregon Health and Science University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a healthy woman between 18 and 40 years old.I regularly take NSAIDs for pain or inflammation.I have a metabolic disorder.I am not taking drugs that affect UPA metabolism or are related to CYP3A4.
Research Study Groups:
This trial has the following groups:- Group 1: Active CYP3A5 Allele
- Group 2: Inactive CYP3A5 Allele
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any age restrictions on participation in this research project?
"According to the study's prerequisites, only those aged between 18 and 40 can participate in this clinical trial."
Answered by AI
Am I eligible to be involved in this research project?
"To be eligible for this trial, volunteers must use contraception and fit within the parameters of 18 to 40 years old. The research team is looking to recruit a total of 140 participants."
Answered by AI
Is Active CYP3A5 Allele a risk-free option for patients?
"Our team at Power gave Active CYP3A5 Allele a safety rating of 3, as this is an approved Phase 4 trial and thus the treatment has been deemed safe."
Answered by AI
Is this study currently accepting volunteers?
"As per clinicaltrials.gov, this medical trial is not accepting participants at present; the original posting was on January 31st 2023 and it has been last edited as of April 1st 2023. Fortunately, there are 199 other studies currently recruiting patients that may be suitable for those interested in participating in a clinical trial."
Answered by AI
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