Spots Global Cancer Trial Database for Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
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Trial Identification
Brief Title: Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
Official Title: An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma
Study ID: NCT02234115
Conditions
Interventions
Study Description
Brief Summary: The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.
Detailed Description: This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers of Alabama, Homewood, Alabama, United States
Alliance Research Centers, Laguna Hills, California, United States
Genesis Research, LLC, San Diego, California, United States
Idaho Urologic Institute - Meridian, Meridian, Idaho, United States
AdvanceMed Research, Lawrenceville, New Jersey, United States
Carolina Clinical Trials, LLC, Concord, North Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Seattle Urology Research Center, Burien, Washington, United States
AKH Linz GmbH, Department of Urology, Linz, Oberösterreich, Austria
Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology), Salzburg, , Austria
Thomayerova nemocnice Urologické oddělení, Praha, Praha 4 - Krč, Czechia
University Hospital Hradec Králové, Hradec Králové, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
Universitätsklinikum RWTH Aachen, Klinik für Urologie, Aachen, Nordrhein-Westfalen, Germany
PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos, Kaunas, , Lithuania
PI Klaipėda University Hospital, Klaipėda, , Lithuania
PI Vilnius University Hospital, Santariškių Klinikos, Vilnius, , Lithuania
Uniwersyteckie Centrum Kliniczne, Klinika Urologii, Gdańsk, , Poland
Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej, Warzawa, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego, Warzawa, , Poland
"DERMED" Centrum Medyczne Sp. z o.o., Łódź, , Poland
UROCENTRUM MILAB, s.r.o., Prešov, , Slovakia
Fakultná nemocnica s poliklinikou Žilina Urológia, Žilina, , Slovakia
Kaohsiung Veteran General Hospital (VGHKS), Kaohsiung City, Pingtung, Taiwan
China Medical University Hospital (CMUH), Taichung City, Taichung, Taiwan
Taichung Veteran General Hospital (VGHTC), Taichung City, Taichung, Taiwan
National Cheng Kung University Hospital (NCKUH), Tainan City, Tainan, Taiwan
National Taiwan University Hospital (NTUH), Taipei City, Taipei, Taiwan
Chang Gung Memorial Hospital, LinKou (CGMH-LK), Taoyuan City, , Taiwan
Contact Details
Name: John Mao, PhD
Affiliation: Foresee Pharmaceuticals Co., Ltd.
Role: STUDY_DIRECTOR
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