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This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.
This study is designed to determine if multiple oral doses of VI-0521 would alter the pharmacokinetics of an oral contraceptive in healthy female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Contraceptive | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ethinyl estradiol, norethindrone, VI-0521 | Drug | Oral contraceptive |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK of the Oral contraceptive agent | 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects | 31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyin Yee | VIVUS LLC | Study Director |
| Scott Sharples, M.D. | MDS Pharma Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Phoenix | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009640 | Norethindrone |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |