RecruitingPhase 4NCT05674513

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy


Sponsor

Oregon Health and Science University

Enrollment

140 participants

Start Date

Jan 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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

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Interventions

DRUGUlipristal acetate

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


Locations(1)

OHSU

Portland, Oregon, United States

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NCT05674513


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