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| ID | Type | Description | Link |
|---|---|---|---|
| AZD6140/OC Study |
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The purpose of this study is to examine the effect of co-administration of AZD6140 and NordetteĀ® on the blood levels of certain female hormones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6140 | Drug | 90 mg tablet taken by mouth 2 times a day for 21 days per cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and NordetteĀ® | At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of various other hormones following concomitant oral administration of AZD6140 and NordetteĀ® | At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. | |
| Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and NordetteĀ® |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | AstraZeneca | Study Director |
| Audrey, Martinez, MD | SeaView Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Miami | Florida | United States |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Levonorgestrel and Ethinyl Estradiol (NordetteĀ®) |
| Drug |
1 tablet taken by mouth once a day for 28 days per cycle |
|
|
| At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2. |
| Safety and tolerability of AZD6140 when co-administered with NordetteĀ® | Screening through completion of the study |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |