Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

NCT05674513 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: OHSU IRB 249521R01HD105866-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptive Usage

Keywords

Ulipristal acetate; Emergency contraception

Outcome Measures

Primary Outcomes (2)

• 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)

• Concentration of UPA

  mean concentration maximum (Cmax) for UPA

  5 days after taking study drug

Study Arms (2)

Active CYP3A5 Allele

ACTIVE COMPARATOR

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

Drug: Ulipristal acetate

Inactive CYP3A5 Allele

ACTIVE COMPARATOR

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

Drug: Ulipristal acetate

Interventions

Ulipristal acetate DRUG

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

Active CYP3A5 Allele; Inactive CYP3A5 Allele

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Contraception Behavior

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• ALISON EDELMAN, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of OB/GYN

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, OB/GYN

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 6, 2023
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)