Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

NCT ID: NCT05674513

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2027-12-31

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.

Conditions

Contraceptive Usage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active CYP3A5 Allele

Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles

Group Type: ACTIVE_COMPARATOR

Ulipristal acetate

Intervention Type: DRUG

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

Inactive CYP3A5 Allele

Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles

Group Type: ACTIVE_COMPARATOR

Ulipristal acetate

Intervention Type: DRUG

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

Interventions

Ulipristal acetate

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Professor, OB/GYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ALISON EDELMAN, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Women's Health Research Unit Department of OB/GYN

Role: CONTACT

whru@ohsu.edu

503-494-3666

Other Identifiers

1R01HD105866-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU IRB 24952

Identifier Type: -

Identifier Source: org_study_id