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Last Updated: November 24, 2020

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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
NCT00001259 A Treatment Study for Premenstrual Syndrome (PMS) Completed National Institute of Mental Health (NIMH) Phase 1 1992-08-11 This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001322 The Effects of Reproductive Hormones on Mood and Behavior Completed National Institute of Mental Health (NIMH) N/A 1994-06-09 This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies. ...
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.
>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 49
Infertility 10
Prostate Adenocarcinoma 10
Endometriosis 8
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Condition MeSH

Condition MeSH for Leuprolide Acetate
Intervention Trials
Prostatic Neoplasms 73
Adenocarcinoma 19
Infertility 11
Puberty, Precocious 9
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Clinical Trial Locations for Leuprolide Acetate

Trials by Country

Trials by Country for Leuprolide Acetate
Location Trials
United States 510
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 27
Texas 25
California 24
Michigan 21
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 32
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Leuprolide Acetate
Clinical Trial Phase Trials
Completed 52
Not yet recruiting 26
Recruiting 24
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Clinical Trial Sponsors for Leuprolide Acetate

Sponsor Name

Sponsor Name for Leuprolide Acetate
Sponsor Trials
National Cancer Institute (NCI) 31
M.D. Anderson Cancer Center 7
Abbott 6
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Sponsor Type

Sponsor Type for Leuprolide Acetate
Sponsor Trials
Other 116
Industry 55
NIH 43
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