Bioequivalence study of Microrelin 11.25 compared to Dipherelin 11.25 mg in patients with metastatic prostate cancer

Bioequivalence study of slow-release injectable drug Microrelin 11.25 (Triptorelin manufactured by Homapharmed company) compared to Dipherelin 11.25 mg (Triptorelin manufactured by Ipsen Company) in patients with metastatic prostate cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240120060741N2

Enrollment

Registered

2025-01-12

Start date

2025-01-20

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Mtastatic prostate cancer. Malignant neoplasm of male genital organ, unspecified

Interventions

Intervention 1: Test group: slow-release injectable drug Microrelin 11.25 mg (Triptorelin manufactured by Homapharmed company). Intervention 2: Control group: slow release injectable drug Dipherelin

Eligibility

Sex/Gender

Male

Age

50 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients aged 50 to 90 years old with metastatic prostate cancer indicate hormonotherapy Not having immune disorders (e.g. AIDS, Multiple Sclerosis), cardiovascular, neurological ,renal or hepatic disorders Not taking immunosuppressant medication in last 2 months Signed the informed consent form and be able to accompany with the study process

Exclusion criteria

Exclusion criteria: History of allergic reactions to GnRH-A drugs History of previous chemotherapy Having diseases other than metastatic prostate cancer History of orchiectomy, history of radiotherapy and chemotherapy, as well as patients who have previously received hormone therapy (secondary) Patients are candidates for treatment with abiraterone, lutetium, enzalutamide, docetaxel, and first- and second-generation antiandrogens such as flutamide.

Design outcomes

Primary

Measure	Time frame
Comparison of Prostate-specific antigen (PSA) serum levels in patients receiving Microrelin and Dipherelin 11/75 mg. Timepoint: Blood samples will be taken at 1,2, 4, and 8 hours after administration. and then on days 2, 7, 14, 21, 28, 42, 60, 75, and 90. Method of measurement: Prostate-specific antigen (PSA) can be measured using two methods: a gold immunochromatographic strip or an ELISA-based system.;Comparison of testosterone serum level in patients receiving Microrelin and Dipherelin 11/75 mg. Timepoint: Blood samples will be taken at 1,2, 4, and 8 hours after administration. and then on days 2, 7, 14, 21, 28, 42, 60, 75, and 90. Method of measurement: Testosterone levels are measured using an ELISA method.	—

Measure

Time frame

Comparison of Prostate-specific antigen (PSA) serum levels in patients receiving Microrelin and Dipherelin 11/75 mg. Timepoint: Blood samples will be taken at 1,2, 4, and 8 hours after administration. and then on days 2, 7, 14, 21, 28, 42, 60, 75, and 90. Method of measurement: Prostate-specific antigen (PSA) can be measured using two methods: a gold immunochromatographic strip or an ELISA-based system.;Comparison of testosterone serum level in patients receiving Microrelin and Dipherelin 11/75 mg. Timepoint: Blood samples will be taken at 1,2, 4, and 8 hours after administration. and then on days 2, 7, 14, 21, 28, 42, 60, 75, and 90. Method of measurement: Testosterone levels are measured using an ELISA method.

—

Secondary

Measure	Time frame
Any solicited adverse events. Timepoint: Up to 90 days after administration. Method of measurement: Direct observation and reporting.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSetayesh Sadeghi

Caropharmed

s.sadeghi@caropharmed.com+98 21 9120 0238

Outcome results

None listed

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