Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
- Registration Number
- NCT05674513
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active CYP3A5 Allele Ulipristal acetate Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles Inactive CYP3A5 Allele Ulipristal acetate Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles
- Primary Outcome Measures
Name Time Method Delay in follicular rupture over 1 menstrual cycle (assessed up to approximately 30 days) Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or \>50% reduction in size of the leading follicle
Concentration of UPA 5 days after taking study drug mean concentration maximum (Cmax) for UPA
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
OHSU
🇺🇸Portland, Oregon, United States
OHSU🇺🇸Portland, Oregon, United States