OHSU
Portland, Oregon, 97239, United States
Location status: Recruiting
NCT Number: NCT05674513
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.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Phase 4
Portland, Oregon, 97239, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles
Time frame: 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
Time frame: 5 days after taking study drug
mean concentration maximum (Cmax) for UPA
Contact information is provided by the study sponsor or research team.
Oregon Health and Science University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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