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Generated: March 24, 2019

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CLINICAL TRIALS PROFILE FOR TRELSTAR

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Clinical Trials for Trelstar

Trial ID Title Status Sponsor Phase Summary
NCT01467882 Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty Completed Debiopharm International SA Phase 3 The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).
NCT02090114 RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) Recruiting National Cancer Institute (NCI) Phase 2 Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide or abiraterone in men with metastatic CRPC who previously progressed on either of these agents. The study will enroll two cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); and men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B).
NCT02090114 RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) Recruiting Sidney Kimmel Comprehensive Cancer Center Phase 2 Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide or abiraterone in men with metastatic CRPC who previously progressed on either of these agents. The study will enroll two cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); and men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B).
NCT02286921 Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance Recruiting United States Department of Defense Phase 2 Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve primary and secondary objectives vs. enzalutamide as standard therapy.
NCT02286921 Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance Recruiting Sidney Kimmel Comprehensive Cancer Center Phase 2 Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve primary and secondary objectives vs. enzalutamide as standard therapy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Trelstar

Condition Name

Condition Name for Trelstar
Intervention Trials
Prostate Cancer 4
Stage IIB Prostate Cancer 1
Castration-resistant Prostate Cancer Patients With Oligometastases 1
Stage IIA Prostate Cancer 1
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Condition MeSH

Condition MeSH for Trelstar
Intervention Trials
Prostatic Neoplasms 7
Adenocarcinoma 1
Puberty, Precocious 1
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Clinical Trial Locations for Trelstar

Trials by Country

Trials by Country for Trelstar
Location Trials
United States 24
Mexico 1
Chile 1
Canada 1
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Trials by US State

Trials by US State for Trelstar
Location Trials
Maryland 3
California 3
New York 2
New Jersey 2
Florida 2
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Clinical Trial Progress for Trelstar

Clinical Trial Phase

Clinical Trial Phase for Trelstar
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Trelstar
Clinical Trial Phase Trials
Recruiting 5
Completed 1
Not yet recruiting 1
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Clinical Trial Sponsors for Trelstar

Sponsor Name

Sponsor Name for Trelstar
Sponsor Trials
Sidney Kimmel Comprehensive Cancer Center 2
National Cancer Institute (NCI) 2
Watson Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Trelstar
Sponsor Trials
Other 7
Industry 4
NIH 2
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