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Clincal Trials

Office based urology trials

Richard W. Casey, MD,1 Jack Barkin, MD2 The Male Health Centre, Oakville, Ontario, Canada 2Humber River Regional Hospital, University of Toronto, Toronto, Ontario, Canada

BENIGN PROSTATIC HYPERPLASIA TOP

A DOSE-FINDING, MULTI-CENTRE, DOUBLE-BLIND, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED TRIAL TO INVESTIGATE EFFICACY AND SAFETY OF DEGARELIX IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH
Trial ID: FE200486
Coordination: CMX Research Inc.
Trial design: This study is designed as a double-blind study to assess safety and efficacy of study drug (degarelix) in male subjects who present with lower urinary tract symptoms in association with BPH.
Patient population: Lower urinary tract symptoms due to benign prostatic hyperplasia.
Sample size: n = 380
A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE NEW OR WORSENING LENS OPACIFICATIONS IN SUBJECTS WITH NON-METASTATIC PROSTATE CANCER RECEIVING DENOSUMAB FOR BONE LOSS DUE TO ANDROGEN-DEPRIVATION THERAPY
Trial ID: 20080560
Coordination: CMX Research Inc.
Trial design: This is a multi-center, randomized, double-blind, placebo-controlled study in patients with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT). Approximately 760 patients will be randomly assigned to receive placebo or denosumab at a dose of 60 mg once every 6 months (Q6M) in a 1:1 allocation ratio for 12 months (i.e. study day 1 and month 6).
Patient population: Patients with baseline LOCS III status (< 3.0 at all sites [P,C,NO] vs. ≥ 3.0 at any of these sites), age group (< 70, 70 to 80 years, > 80 years), and subject-reported history of cataract (yes/no).
Sample size: n = 760
AN OPEN-LABEL, MULTI-CENTRE, RANDOMIZED, PARALLEL-ARM ONE-YEAR TRIAL, COMPARING THE EFFICACY AND SAFETY OF DEGARELIX THREE-MONTH DOSING REGIMEN WITH GOSERELIN ACETATE IN PATIENTS WITH PROSTATE CANCER REQUIRING ANDROGEN DEPRIVATION THERAPY
Trial ID: 200486 C35
Coordination: CMX Research Inc.
Trial design: This is an open-label, multi-centre, randomized, parallel-arm trial with subcutaneous (s.c.) injections of degarelix three-month depot or goserelin acetate three-month implant in patients with advanced prostate cancer.
Patient population: Male patients 18 years or older. Patients with histologically confirmed adenocarcinoma of the prostate for which endocrine treatment is indicated.
Sample size: n = 825

PROSTATE CANCER TOP

BONE HEALTH OBSERVATIONAL STUDY
Trial ID: AZ-CMX-03
Coordination: CMX Research Inc.
Trial design: A prospective study to evaluate the incidence of skeletal related events in prostate cancer patients undergoing androgen deprivation therapy (ADT). Patient population: Male patients undergoing ADT for locally advance prostate cancer.
Sample size: n = 600
ELIGARD® OBSERVATIONAL REGISTRY
Trial ID: ELIGARD® OBSERVATIONAL REGISTRY
Coordination: CMX Research Inc.
Trial design: Long term treatment effi cacy, safety and outcome data collection on prostate cancer patients undergoing ADT Therapy with Eligard® utilizing web based database. Patient population: Male patient with prostate cancer starting ADT with Eligard®.
Sample size: n = 300

SEMEN, PMF AND POST-DRE URINE STUDY TOP

THE IDENTIFICATION OF A DIAGNOSTIC BIOMARKER(S) IN MINIMALLY INVASIVELY COLLECTED SEMEN, PMF AND POST-DRE URINE FOR EARLY SCREENING OF PROSTATE
Trial ID: CUG-004v1
Coordination: CMX Research Inc.
Trial design: This is an epidemiological study analyzing semen, PMF and post-DRE urine samples to identify levels of a genetic biomarker for the purpose of screening and monitoring prostate cancer. Study design is controlled using a test group of samples (diagnosis of prostate malignancy) and a control group of samples (no diagnosis of prostate malignancy).
Patient population: Male patients under the age of 70.
Sample size: n = 100

OVERACTIVE BLADDER TOP

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY OF THE SAFETY AND EFFICACY OF A SINGLE TREATMENT OF BOTOX (BOTULINUM TOXIN TYPE A)
Trial ID: 191622-095
Coordination: CMX Research Inc.
Trial design: A multi-center, double-blind, randomized, placebo-controlled, parallel-group study of the safety and efficacy of a single treatment of Botox (Botulinum Toxin Type A). Purified neurotoxin complex followed by a repeat treatment with BOTX as applicable in patients with idiopathic overactive bladder. Patient population: Patients with symptoms of iOAB with urinary urge incontinence for at least 6 months, whose symptoms have not been adequately managed with anticholinergic therapy.
Sample size: 546
Trial design: Phase III to evaluate the effi cacy and safety of DR-3001 (Oxybutynin Vaginal Ring releasing 4 mg or 6 mg/day) versus placebo over 12 weeks, in women diagnosed with overactive bladder who have symptoms of pure or predominantly urge incontinence, urgency and frequency.
Patient population: 1161
Sample size & endpoint: n = 1548, the primary measure of effi cacy will be the change from Visit 1 (Baseline) to Visit 5 (Treatment Week 12/Early Withdrawal) in total weekly number of incontinence episodes.
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF THE BETA-3 AGONIST YM178 (25 MG AND 50 MG) IN SUBJECTS WITH SYMPTOMS OF OVERACTIVE BLADDER
Trial ID: 178-CL-074
Coordination: CMX Research Inc.
Trial design: This is a multinational, multicenter, double-blind, randomized parallel group, placebo controlled phase III study. Subjects will be enrolled into a single-blind, 2-week placebo run-in period followed by randomized, double-blind placebo controlled, 12-week treatment period (ratio 1:1:1). There are a total of 6 visits.
Patient population: Outpatient male or female subjects > than or equal to 18 years of age with symptoms of OAB for ≥ 3 months. At baseline subjects have average of ≥ to 8 micturitions per 24 hours and ≥ 1 urgency episode with or without incontinence per 24 hour period.
Sample size: Approximately 1821 enrolled, 1311 randomized, and 1113 evaluable subjects.

PAINFUL BLADDER SYNDROME TOP

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EXPLORE THE EFFICACY, SAFETY, AND TOLERABILITY OF JNJ-42160443 IN SUBJECTS WITH INTERSTITIAL CYSTITIS AND/OR PAINFUL BLADDER SYNDROME
Trial ID: 2160443PA12005
Coordination: CMX Research Inc.
Trial design: A Phase IIB study to explore the efficacy of JNJ-42160443 compared to placebo using the change in the mean of the average pain intensity at 12 weeks from the baseline pain intensity score, and to assess the safety and tolerability of this treatment in subjects with moderate to severe chronic pain from interstitial cystitis and /or painful bladder syndrome. Patient population: Men and women aged 18-80 years, inclusive, with moderate to severe, chronic pain from IC and/or PBS.
Sample size: 70

PREMATURE EJACULATION
ERECTILE DYSFUNCTIONTOP

A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF AN SSRI IN MEN WITH PREMATURE EJACULATION AND CONCOMITANT ERECTILE DYSFUNCTION TREATED WITH A PHOSPHODIETERASE-5 INHIBITOR
Trial ID: RO96769-PRE-3008
Coordination: CMX Research Inc.
Trial design: This study is designed to determine the efficacy and safety of a selective serotonin reuptake inhibitor in men with premature ejaculation and erectile dysfunction who are currently receiving stable treatment with a PDE-5 inhibitor for their erectile dysfunction. Patient population: Male subjects over 18 years of age with co-existing conditions of Erectile dysfunction (ED) and premature ejaculation (PE).
Sample size: n = 656