Back to resultsDisparities in Emergency Contraceptive Metabolism Dictate Efficacy
Primary Purpose
Contraceptive Usage
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ulipristal acetate
Sponsored by
About this trial
This is an interventional treatment trial for Contraceptive Usage focused on measuring Ulipristal acetate, Emergency contraception
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
Sites / Locations
- OHSURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Active CYP3A5 Allele
Inactive CYP3A5 Allele
Arm Description
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles
Outcomes
Primary Outcome Measures
Delay in follicular rupture
Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or >50% reduction in size of the leading follicle
Concentration of UPA
mean concentration maximum (Cmax) for UPA
Secondary Outcome Measures
Full Information
NCT ID
NCT05674513
First Posted
December 15, 2022
Last Updated
April 10, 2023
Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05674513
Brief Title
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Official Title
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
Each of us can respond differently to a drug or medication based on our genetics. An emergency contraceptive, ulipristal acetate or UPA, normally works by stopping or delaying the ovary from releasing an egg (ovulation). Our bodies break down UPA in order to use it through a system call the cytochrome P450 pathway but this pathway can be faster or slower depending on our genetics. The investigators want to learn more about how our individual genetic differences in this pathway change how the ovary responds to UPA. The overall goal of this research is to improve the effectiveness of emergency contraception for all people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraceptive Usage
Keywords
Ulipristal acetate, Emergency contraception
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active CYP3A5 Allele
Arm Type
Active Comparator
Arm Description
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles
Arm Title
Inactive CYP3A5 Allele
Arm Type
Active Comparator
Arm Description
Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles
Intervention Type
Drug
Intervention Name(s)
Ulipristal acetate
Intervention Description
Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles
Primary Outcome Measure Information:
Title
Delay in follicular rupture
Description
Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or >50% reduction in size of the leading follicle
Time Frame
over 1 menstrual cycle (assessed up to approximately 30 days)
Title
Concentration of UPA
Description
mean concentration maximum (Cmax) for UPA
Time Frame
5 days after taking study drug
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Department of OB/GYN
Phone
503-494-3666
Email
whru@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALISON EDELMAN, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
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