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The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-02413873 | Experimental | PF-2413873 active treatment |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-02413873 100 mg QD | Drug | 100 mg of PF-02413873 oral suspension once daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests. | 1 month | |
| PF-02413873 pharmacokinetics | 1 month | |
| Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Investigational Site |
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| PF-02413873 1500 mg QD |
| Drug |
1500 mg of PF-02413873 oral suspension once daily for 14 days |
|
| PF-02413873 20 mg QD | Drug | 20 mg of PF-02413873 oral suspension once daily for 14 days |
|
| PF-02413873 500 mg QD | Drug | 500 mg of PF-02413873 oral suspension once daily for 14 days |
|
| PF-02413873 Placebo | Drug | PF-0241383 Placebo once daily for 14 days |
|
| Overland Park |
| Kansas |
| 66211 |
| United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Brussels | 1070 | Belgium |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C568445 | 4-(3-cyclopropyl-1-(methylsulfonylmethyl)-5-methyl-1H-pyrazol-4-yl)oxy-2,6-dimethylbenzonitrile |
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