Bioequivalence study of two Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer

Comparative bioequivalence study of two sustained release Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer based on biologic response (serum PSA and Testosterone levels)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016090410178N10

Enrollment

Registered

2016-10-29

Start date

2016-10-22

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

Metastatic prostate cancer. Malignant neoplasm of prostate

Interventions

Intervention 1: Diphereline (Triptorelin acetate manufactured by IPSEN, France) 3.75mg IM every 28 days for 3 doses. Intervention 2: Decareline (Triptorelin acetate manufactured by Ronak Darou, Iran)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Metastatic prostate cancer Signing written consent form

Exclusion criteria

Exclusion criteria: Hypothalamic pituitary gonadal axis dysfunction Malignancy other than prostate cancer Treatment with other Gonadotropin Releasing Hormone (GnRH) analogues, hormones, radiotherapy or chemotherapy during recent three months Allergy to GnRH, GnRH analogues or to any component of medications

Design outcomes

Primary

Measure	Time frame
Prostate Specific Antigen (PSA) serum level. Timepoint: Before injection of each dose of medication for 3 months. Method of measurement: Biomerieux Vidas kits.;Testostrone serum level. Timepoint: Before injection of each dose of medication for 3 months. Method of measurement: Biomerieux Vidas kits.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Sistanizad

Shahid Beheshti University of Medical Sciences

sistanizadm@sbmu.ac.ir+98 218800087

Outcome results

None listed

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