Contraceptive Usage
Conditions
Keywords
Ulipristal acetate, Emergency contraception
Brief summary
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
DRUGUlipristal acetate
Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles
Sponsors
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delay in follicular rupture | over 1 menstrual cycle (assessed up to approximately 30 days) | Follicular rupture (yes/no) by ultrasound. Defined as the disappearance of or \>50% reduction in size of the leading follicle |
| Concentration of UPA | 5 days after taking study drug | mean concentration maximum (Cmax) for UPA |
Countries
United States
Contacts
CONTACTWomen's Health Research Unit Department of OB/GYN
PRINCIPAL_INVESTIGATORALISON EDELMAN, MD
Oregon Health and Science University
Outcome results
None listed