Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Jan 4, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding why some women experience failure when using emergency contraception, while others do not. The researchers want to investigate if genetic differences in how people's bodies process the medication play a role in this. The study is currently looking for healthy women aged 18 to 40 who have regular menstrual cycles (occurring every 21 to 35 days) and who show signs of ovulation.

If you decide to participate, you will be asked to provide information about your health and menstrual cycle. However, there are some important things to consider: you cannot be pregnant, breastfeeding, or trying to get pregnant, and you should not have certain health conditions or be taking specific medications that could affect the study. This trial aims to improve the effectiveness of emergency contraception for everyone, and your participation could help researchers learn valuable information.

Gender

FEMALE

Eligibility criteria

• 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