Bioequivalence study of two Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer
Phase 2
Recruiting
- Conditions
- Metastatic prostate cancer.Malignant neoplasm of prostate
- Registration Number
- IRCT2016090410178N10
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
Metastatic prostate cancer
Signing written consent form
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method