Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

OHSU IRB 24952

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.

2023-01-09

2026-12-31

2027-12-31

Recruiting

Early phase I

140

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2023-04-11