Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130603013572N8

Enrollment

Registered

2024-03-21

Start date

2024-04-03

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Triptorelin, Bioequivalent, Pharmacokinetics. Malignant neoplasm of prostate

Interventions

Intervention 1: Intervention group: Single dose administration of injectable sustained release formulations of Triptorelin (Decatrip®) in Patients with prostate cancer. Intervention 2: Control group:

Eligibility

Sex/Gender

Male

Age

No minimum to 65 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadreza Rouini

Tehran University of Medical Sciences

rouini@tums.ac.ir02164120

Outcome results

None listed

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