Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
ConditionContraceptive Usage
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Pregnant, seeking pregnancy, or breastfeeding
Known allergy to study medication
Recent use of hormonal contraception
Irregular periods (<21 days or >35 day cycles)
Trial design
Design model
Single group
Treatments tested in this trial
Ulipristal acetate
DrugEvaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Active CYP3A5 AlleleActive comparator 1 intervention
Group B: Inactive CYP3A5 AlleleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Delay in follicular rupture
Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or \>50% reduction in size of the leading follicle
Time frame
over 1 menstrual cycle (assessed up to approximately 30 days)2
Concentration of UPA
mean concentration maximum (Cmax) for UPA
Time frame
5 days after taking study drugSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov