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Evaluate the Safety, Efficacy and Pharmacokinetics of Leuprolide Injectable Emulsion in Advanced Prostate Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprolide Injectable Emulsion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide Injectable Emulsion (CAMCEVI®) | Drug | Leuprolide Injectable Emulsion (CAMCEVI®),Subcutaneous injection,Once every 24 weeks for a total of 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative probability of maintaining serum testosterone at a castrate level (≤ 50 ng/dL) from the end of 28 days after the first dose to the end of 168 days after the second dose. | To evaluate the castrate level maintenance of Leuprolide Injectable Emulsion from the end of 28 days after the first dose to the end of 168 days after the second dose, with serum testosterone as a surrogate parameter for the assessment of efficacy and a castrate level of 50 ng/dL. | from the end of 28 days after the first dose to the end of 168 days after the second dose. |
| including but not limited to:adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), injection site reactions, local tolerance, etc. | To evaluate the safety and tolerability of Leuprolide Injectable Emulsion after two subcutaneous injections in patients with advanced prostate cancer. | 336 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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