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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170225032759N3

Enrollment

Registered

2021-04-06

Start date

2022-02-26

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-metastatic or metastatic prostate cancer.

Interventions

Intervention 1: Intervention group: ?Diphereline 11.25 mg single dose for 3 months. Intervention 2: Intervention group: Variopeptyl 11.25 mg single dose for 3 months.

Eligibility

Sex/Gender

Male

Age

50 Years to 90 Years

Inclusion 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

Exclusion criteria: • Sensitivity to drugs, especially GnRH-A • Previous history of chemotherapy • Other diseases

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).;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.;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.	—

Measure

Time frame

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).;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.;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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir mansour Jalali Nadooshan

Varian Pharmed Co

info@varianpharmed.com+98 21 4448 3009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026