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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR LEUPROLIDE ACETATE

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505(b)(2) Clinical Trials for LEUPROLIDE ACETATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00626431 A Study of Leuprolide to Treat Prostate Cancer Completed Abbott Phase 3 2008-02-01 To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for LEUPROLIDE ACETATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003124 Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 1997-05-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.
NCT00003124 Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer Completed Herbert Irving Comprehensive Cancer Center Phase 2 1997-05-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.
NCT00003653 Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1999-01-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. It is not yet known which androgen suppression regimen is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for prostate cancer.
NCT00003653 Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer Completed Southwest Oncology Group Phase 3 1999-01-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. It is not yet known which androgen suppression regimen is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for prostate cancer.
NCT00003653 Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer Completed NCIC Clinical Trials Group Phase 3 1999-01-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. It is not yet known which androgen suppression regimen is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for LEUPROLIDE ACETATE

Condition Name

Condition Name for LEUPROLIDE ACETATE
Intervention Trials
Prostate Cancer 48
Infertility 9
Prostate Adenocarcinoma 8
Endometriosis 7
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Condition MeSH

Condition MeSH for LEUPROLIDE ACETATE
Intervention Trials
Prostatic Neoplasms 66
Adenocarcinoma 17
Infertility 10
Puberty, Precocious 8
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Clinical Trial Locations for LEUPROLIDE ACETATE

Trials by Country

Trials by Country for LEUPROLIDE ACETATE
Location Trials
United States 503
Canada 45
Italy 13
Japan 11
Belgium 10
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Trials by US State

Trials by US State for LEUPROLIDE ACETATE
Location Trials
New York 26
Texas 24
California 24
Michigan 20
Florida 20
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Clinical Trial Progress for LEUPROLIDE ACETATE

Clinical Trial Phase

Clinical Trial Phase for LEUPROLIDE ACETATE
Clinical Trial Phase Trials
Phase 4 16
Phase 3 28
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for LEUPROLIDE ACETATE
Clinical Trial Phase Trials
Completed 50
Recruiting 24
Not yet recruiting 16
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Clinical Trial Sponsors for LEUPROLIDE ACETATE

Sponsor Name

Sponsor Name for LEUPROLIDE ACETATE
Sponsor Trials
National Cancer Institute (NCI) 26
Abbott 6
M.D. Anderson Cancer Center 6
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Sponsor Type

Sponsor Type for LEUPROLIDE ACETATE
Sponsor Trials
Other 106
Industry 52
NIH 35
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