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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05674513
Other study ID # OHSU IRB 24952
Secondary ID 1R01HD105866-01A
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 9, 2023
Est. completion date December 31, 2027

Study information

Verified date April 2023
Source Oregon Health and Science University
Contact Women's Health Research Unit Department of OB/GYN
Phone 503-494-3666
Email whru@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ulipristal acetate
Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles

Locations

Country Name City State
United States OHSU Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Delay in follicular rupture Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or >50% reduction in size of the leading follicle over 1 menstrual cycle (assessed up to approximately 30 days)
Primary Concentration of UPA mean concentration maximum (Cmax) for UPA 5 days after taking study drug
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