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Recruiting

NCT Number: NCT05674513

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

OHSU

Portland, Oregon, 97239, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulipristal Acetate

Drug

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

Primary outcomes

  1. Delay in follicular rupture

    Time frame: over 1 menstrual cycle (assessed up to approximately 30 days)

    Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or >50% reduction in size of the leading follicle

  2. Concentration of UPA

    Time frame: 5 days after taking study drug

    mean concentration maximum (Cmax) for UPA

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Department of OB/GYN

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2023
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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