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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD105866-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CYP3A5 Allele | Active Comparator | Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles |
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| Inactive CYP3A5 Allele | Active Comparator | Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal acetate | Drug | Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Department of OB/GYN | Contact | 503-494-3666 | whru@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| ALISON EDELMAN, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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