Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Conditions
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Contraceptive Usage

Intervention / Treatment
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* Drug: Ulipristal acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active CYP3A5 Allele<br>Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles | Drug: Ulipristal acetate<br>* Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles<br>|
| Active Comparator: Inactive CYP3A5 Allele<br>Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles | Drug: Ulipristal acetate<br>* Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in follicular rupture | Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or >50% reduction in size of the leading follicle | over 1 menstrual cycle (assessed up to approximately 30 days) | 
| Concentration of UPA | mean concentration maximum (Cmax) for UPA | 5 days after taking study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulipristal acetate, Emergency contraception