Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ulipristal acetate.
- Who it may be relevant to
- Registry conditions: Contraceptive Usage. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Drug Ulipristal acetate
Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles
Primary outcome measures
- Delay in follicular rupture [Time frame: over 1 menstrual cycle (assessed up to approximately 30 days)]
- Concentration of UPA [Time frame: 5 days after taking study drug]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- OHSU — Portland
Identifiers
NCT: NCT05674513 · STUDY00024952 · 1R01HD105866-01A1