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Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
NCT05674513Phase 4
Key facts
- Status
- Recruiting
- Start
- Jan 2023
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Oregon Health & Science University
- Modality
- Small Molecules
- Drugs
- ulipristal
- Conditions
- contraception
01
Overview
Phase 4 trial of ulipristal in contraception (2 arms), sponsored by Oregon Health & Science University. Primary endpoints: Delay in follicular rupture at 30 days and Concentration of Ulipristal Acetate at 5 days. Started Jan 2023; status: recruiting.
02
Design
2 arms- Study design
- Non-randomized
Active CYP3A5 Allele
Individuals with active CYP3A5 alleles
Inactive CYP3A5 Allele
Individuals without active CYP3A5 alleles
03
Who it enrols
Healthy women aged 18-40 with regular ovulatory cycles, excluding those pregnant, breastfeeding, smoking, or using hormonal contraception, NSAIDs, or CYP3A-interacting drugs.
04
Endpoints
Primary
Delay in follicular rupture
Concentration of Ulipristal Acetate
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