Actively Recruiting
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Led by Oregon Health and Science University · Updated on 2024-08-19
140
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying why some women may have a higher risk of emergency contraceptive failure, focusing on how genetic differences affect this risk. This study explores how variations in genes related to drug metabolism influence the effectiveness of ulipristal acetate (UPA), an emergency contraceptive that works by stopping or delaying ovulation. The goal is to understand these genetic factors to improve emergency contraception for everyone. Participants receive a single 30mg oral dose of ulipristal acetate. The study compares women with active CYP3A5 gene alleles to those without active alleles, assessing how their bodies process the drug and how their ovaries respond. This is a phase 4, non-randomized trial without blinding, with two groups based on genetic differences. During the study, participants will be monitored over about one menstrual cycle, approximately 30 days, to see if ovulation is delayed and to measure the concentration of UPA in their bodies five days after taking the drug. Tests include pharmacokinetic and pharmacodynamic assessments to understand drug metabolism and effects. Researchers also track menstrual cycles and hormone levels to confirm ovulation status and ensure participant safety throughout the study period.
CONDITIONS
Brief Title
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy women
- Aged 18 to 40 years
- Regular menstrual cycles occurring every 21 to 35 days
- Ovulatory cycles confirmed by a progesterone level of 3 ng/mL or greater during the luteal phase in the screening cycle
You will not qualify if you...
- Pregnant, seeking pregnancy, or breastfeeding
- Known allergy to the study medication
- Recent use of hormonal contraception
- Irregular menstrual cycles (less than 21 days or more than 35 days)
- Routine use of nonsteroidal anti-inflammatory drugs
- Metabolic disorders
- Smoking
- Any condition that would prevent informed consent
- Use of drugs within 2 weeks before enrollment that affect UPA metabolism or are CYP3A4 inducers, inhibitors, or substrates
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 days
Participants receive one oral dose of Ulipristal acetate 30mg and undergo pharmacokinetic and pharmacodynamic testing to evaluate drug metabolism and ovulation delay.
1 baseline visit and multiple follow-up visits within 5 days
Duration - Up to 30 days
Participants are monitored for up to one menstrual cycle (approximately 30 days) to assess delay in follicular rupture after treatment.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Department of OB/GYN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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