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View trial details
Overview
Official protocol title:
A RANDOMIZED PHASE 3 TRIAL OF METFORMIN IN PATIENTS INITIATING ANDROGEN DEPRIVATION THERAPY AS PREVENTION AND INTERVENTION OF METABOLIC SYNDROME: THE PRIME STUDY
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
METFORMIN
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
PRIME
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
202734
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Closed
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
March 07, 2017
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
ClinicalTrials.gov -
NCT03031821
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
MALE
Accepts healthy volunteers:
No
Locations
Alberta
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Tom Baker Cancer Centre
Calgary, Alberta, T2S 3C3
British Columbia
BC Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9
Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
New Brunswick
Horizon Health Network
Saint John, New Brunswick, E3B 4R3
Newfoundland and Labrador
Central Newfoundland Regional Health Centre
Grand Falls-Windsor, Newfoundland and Labrador, A2A 2E1
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 8V6
Ontario
Northeast Cancer Centre
Greater Sudbury, Ontario, P3E 5J1
Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario, M5G 2M9
Sunnybrook Research Institue
Toronto, Ontario, M4N 3M5
Quebec
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec / Centre hospitalier régional
Trois Rivieres, Quebec, G8Z 3R9
CHU de Quebec - Universite Laval
Ciusss-Chus
Sherbrooke, Quebec, J1H 5N4
McGill University Health Center-Cedar Cancer Center
Montreal, Quebec, H4A 3J1
