RECRUITING

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Conditions

Contraceptive Usage Ulipristal acetate Emergency contraception

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Quick Facts

Study Start:2023-01-09

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05674513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Women's Health Research Unit Department of OB/GYN

CONTACT

503-494-3666

whru@ohsu.edu

Principal Investigator

ALISON EDELMAN, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

OHSU

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

ALISON EDELMAN, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-09

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-01-09

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Ulipristal acetate
Emergency contraception

Additional Relevant MeSH Terms

Contraceptive Usage