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Recruitment centers
#1
Name of recruitment center - English: بیمارستان شهدای تجریش
Name of recruitment center - Persian: Shohada-e-Tajrish Hospital
Full name of responsible person - English: Dr. Hamid Reza Mirzaei
Full name of responsible person - Persian: دکتر حمیدرضا میرزائی
Street address - English: میدان قدس، خیابان دربند
Street address - Persian: Quds Square, Darband St
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1989934148
Phone: +98 21 2271 8000
Fax:
Email: pr-shohada@sbmu.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان شهدای تجریش Name of recruitment center - Persian: Shohada-e-Tajrish Hospital Full name of responsible person - English: Dr. Hamid Reza Mirzaei Full name of responsible person - Persian: دکتر حمیدرضا میرزائی Street address - English: میدان قدس، خیابان دربند Street address - Persian: Quds Square, Darband St City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1989934148 Phone: +98 21 2271 8000 Fax: Email: pr-shohada@sbmu.ac.ir Web page address:
Protocol summary
Study aim
Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
Design
A randomized, two treatment, one period, parallel study
Settings and conduct
This study will be done in Mehr and Imam Khomeini hospitals. 40 Patients with advanced prostate cancer will participate. They will receive a dose of 3.75 mg of triptorelin. Five mL of blood samples will be obtained at 0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration. This is a single blind and parallel study.
Participants/Inclusion and exclusion criteria
Inclusion:
Patients with Prostate Cancer
Availability of the patient for the entire study period and show willingness to adhere to study requirements
Able to give written consent
Exclusion:
History of hypersensitivity to the study drug
History of previous chemotherapy
Renal (serum creatinine twice normal) and hepatic failure (AST and ALT three times normal
Administration of corticosteroids except for topical use
Donation of blood or plasma thirty days before the first day of this study
Vaccination one month before the first day of the study
Participation in a clinical trial one month before the first day of the study
Intervention groups
Single dose administration of injectable sustained release formulations of Triptorelin (Decatrip® or Dipherelin®) in Patients with prostate cancer
Main outcome variables
Drug concentration in serum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130603013572N8
Registration date:2024-03-21, 1403/01/02
Registration timing:prospective
Last update:2025-03-03, 1403/12/13
Update count:1
Registration date
2024-03-21, 1403/01/02
Registrant information
Name
Mohammadreza Rouini
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 9056
Email address
rouini@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
Public title
Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Prostate Cancer
Availability of the patient for the entire study period and show willingness to adhere to study requirements
Able to give written consent
Exclusion criteria:
History of hypersensitivity to the study drug
History of previous chemotherapy
Renal (serum creatinine twice normal) and hepatic failure (AST and ALT three times normal)
Administration of corticosteroids except for topical use
Donation of blood or plasma thirty days before the first day of this study
Vaccination one month before the first day of the study
Participation in a clinical trial one month before the first day of the study
Age
To 65 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Administrating of test or reference product for each subject is determined according to the randomization schedule. The randomization schedule is prepared according to entrancing of subject to the study. Each subject is identified by a number from 1 to 40 according to entrancing of subject to the study. Subjects with odd numbers receive the test drug and the subjects with even number receive the reference drug. (test or reference is the same drug but produced with different manufacturers).
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a single-blind. Patients are blind in this study. Patients are aware of what medication they are taking but do not know whether they are taking the test or reference drug.
The main investigator creates a table using randomization and divides 40 patients in 2 groups which only he knows the details of group. Test or reference drug is prepared base on its brochure, so patients are blinded regarding to the kind of drugs.
Patients are informed that they will be given the Iranian test drug or approved reference drug, although they are unaware of which drug is the test and which is the reference.
Test or reference is the same drug but produced with different manufacturers, so there is not any intervention in treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of The Institute of Pharmaceutical Sciences -Tehran University of Medical
Street address
Keshavarz Blvd., Tehran University of Medical Sciences,Tehran, Iran
City
Tehtan
Province
Tehran
Postal code
1416753955
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.174
Health conditions studied
1
Description of health condition studied
Triptorelin, Bioequivalent, Pharmacokinetics
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
determination of drug concentration in blood serum
Timepoint
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
Method of measurement
Triptorelin ELISA Kit
Secondary outcomes
1
Description
Time to peak drug concentration
Timepoint
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
Method of measurement
observational
2
Description
Maximum drug concentration
Timepoint
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
Method of measurement
observational
3
Description
Area under the concentration–time curves
Timepoint
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
Method of measurement
linear trapezoidal method
Intervention groups
1
Description
Intervention group: Single dose administration of injectable sustained release formulations of Triptorelin (Decatrip®) in Patients with prostate cancer
Category
Treatment - Drugs
2
Description
Control group: Intervention group: Single dose administration of injectable sustained release formulations of Triptorelin (Dipherelin®) in Patients with prostate cancer