Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Contraceptive Usage Clinical Trial

Official title:

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

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
• 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
• 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

Related Conditions & MeSH terms

• Contraceptive Usage
• Emergencies

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