Comparative bioequivalency study (pharmacokinetics- pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer Volunteers
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Protocol summary
This clinical trial at Isfahan Poursina Research Center begins to accept volunteer patients. This study is double-blind and the patient and the principal investigator are unaware of the type of prescription intervention
This clinical trial at Isfahan Poursina Research center and Tehran Khatam-al Anbiya hospital begins to accept volunteer patients. This study is double-blind and the patient and the principal investigator are unaware of the type of prescription intervention
This clinical trial at Isfahan Poursina Research Centercenter and Tehran Khatam-al Anbiya hospital begins to accept volunteer patients. This study is double-blind and the patient and the principal investigator are unaware of the type of prescription intervention
این کارآزمایی در مرکز تحقیقات پورسینا اصفهان شروع به پذیرفتن داوطلبان بیمار می کند. مرکز، پروتکل و مراحل یکسانی را به وسیله ی دستورالعمل یکسان اجرا می کند. این مطالعه دو سو کور است و بیمار و محقق اصلی از نوع مداخله تجویزی بی خبر هستند.
این کارآزمایی در مرکز تحقیقات پورسینا اصفهان و بیمارستان خاتم الانبیاء تهران شروع به پذیرفتن داوطلبان بیمار می کند. مراکز پروتکل و مراحل یکسانی را به وسیله ی دستورالعمل یکسان اجرا می کند. این مطالعه دو سو کور است و بیمار و محقق اصلی از نوع مداخله تجویزی بی خبر هستند.
این کارآزمایی در مرکز تحقیقات پورسینا اصفهان و بیمارستان خاتم الانبیاء تهران شروع به پذیرفتن داوطلبان بیمار می کند. مرکز،مراکز پروتکل و مراحل یکسانی را به وسیله ی دستورالعمل یکسان اجرا می کند. این مطالعه دو سو کور است و بیمار و محقق اصلی از نوع مداخله تجویزی بی خبر هستند.
Recruitment centers
#1
Name of recruitment center - English: Tehran Khatam-al Anbiya hospital
Name of recruitment center - Persian: بیمارستان خاتم الانبیاء تهران
Full name of responsible person - English: Mohammad Reza Noroozi
Full name of responsible person - Persian: محمدرضا نوروزی
Street address - English: Tehran، Rashid Yasemi Street، Upper than Mirdamad St.، Vali- Asr St
Street address - Persian: خیابان ولیعصر، بالاتر از بلوار میرداماد، خیابان رشید یاسمی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 21 4448 4329
Fax:
Email: mrnowroozi@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Tehran Khatam-al Anbiya hospital Name of recruitment center - Persian: بیمارستان خاتم الانبیاء تهران Full name of responsible person - English: Mohammad Reza Noroozi Full name of responsible person - Persian: محمدرضا نوروزی Street address - English: Tehran، Rashid Yasemi Street، Upper than Mirdamad St.، Vali- Asr St Street address - Persian: خیابان ولیعصر، بالاتر از بلوار میرداماد، خیابان رشید یاسمی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 21 4448 4329 Fax: Email: mrnowroozi@sina.tums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of pharmacokinetic parameters based on measurement of serum triptorelin concentration, Evaluation of pharmacodynamic parameters based on measurement of decreased sex hormone levels (reduction of serum testosterone level to castration level) of patients with non-metastatic or metastatic prostate cancer.
Design
This clinical trial is a bioequivalence study, randomized, double-armed, double-blind, parallel, with a 1: 1 ratio of volunteers.
Settings and conduct
This clinical trial at Isfahan Poursina Research center and Tehran Khatam-al Anbiya hospital begins to accept volunteer patients. This study is double-blind and the patient and the principal investigator are unaware of the type of prescription intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Men between the ages of 50 and 90
• patient with non-metastatic or metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• No cardiovascular, cerebral, renal or hepatic problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and .MS
• Able and willing to sign informed consent form;
Exclusion criteria:
• Sensitivity to drugs, especially GnRH-A
Previous history of chemotherapy
• Other diseases
Intervention groups
All volunteers are randomly divided into two groups after definitive confirmation of non-metastatic or metastatic prostate cancer and one group will receive 11.25 mg of extended-release injectable variopeptyl and the other group will receive 11.25 mg of injectable extended-release drug diphererline.
Main outcome variables
measurement of serum triptorelin concentration
General information
Reason for update
Changes in the study population
(According to the principal investigator, the number of people with non-metastatic prostate cancer is very limited, so it is necessary to increase the age range of patients participating in the study from 50 to 70 years to 50 to 90 years. Also adding the population of patients with metastatic prostate cancer to the inclusion criteria).
Acronym
IRCT registration information
IRCT registration number:IRCT20170225032759N3
Registration date:2021-04-06, 1400/01/17
Registration timing:prospective
Last update:2023-04-11, 1402/01/22
Update count:3
Registration date
2021-04-06, 1400/01/17
Registrant information
Name
Amir Mansour Jalali Nadooshan
Name of organization / entity
Varian Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 2485 2480
Email address
a.jalali@varianpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-26, 1400/12/07
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalency study (pharmacokinetics- pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer Volunteers
Public title
Comparative bioequivalency study (pharmacokinetics-pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer Volunteers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Men between the ages of 50 and 90
• patient with non-metastatic or metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• Without cardiovascular, cerebral, renal and liver problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and MS
• Able and willing to sign informed consent form
Exclusion criteria:
• Sensitivity to drugs, especially GnRH-A
• Previous history of chemotherapy
• Other diseases
Age
From 50 years old to 90 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on randomized classification blocks.
The randomization sequence will be created using the RandBETWEEN in Excel program.
Blinding (investigator's opinion)
Double blinded
Blinding description
People who in this study will be unaware of the type of intervention prescribed to patients participating in the study are:
•Patient
• Principal Investigator (Physician)
The person who is aware of the type of intervention prescribed to patients in this study is the central staff that patients will refer to during the previous coordination, and based on the random allocation list, one of the two interventions will be prescribed for them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.MUI.MED.REC.1399.1142
Health conditions studied
1
Description of health condition studied
non-metastatic or metastatic prostate cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of triptorelin concentration
Timepoint
at the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
[D-Trp6]-LHRH
Secondary outcomes
1
Description
Measurement of PSA level
Timepoint
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
PSA tumor marker (ng/ml)
2
Description
Measurement of serum testosterone
Timepoint
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
RIA
3
Description
Measurement of serum FSH
Timepoint
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
RIA
Intervention groups
1
Description
Intervention group: ِDiphereline 11.25 mg single dose for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: Variopeptyl 11.25 mg single dose for 3 months