NL-OMON29795
Completed
Phase 2
Phase II multi-centric, randomised, open-label, parallel-group study to assess the non-inferiority of Pamorelin® 11,25 mg SC injected versus Pamorelin® 11,25 mg IM injected in patients suffering from advanced prostate cancer - Pamoject
Ipsen Pharmaceuticals0 sites210 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- localy advanced prostate cancer
- Sponsor
- Ipsen Pharmaceuticals
- Enrollment
- 210
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Male patients aged 18 years and older
- •Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy.
Exclusion Criteria
- •Hypersensitivity to Pamorelin or drugs with similar structure.
- •Was treated with other IMP within the last 30 days before study entry.
- •Has previously received a LHRH analogue, estrogens or a steroidal anti\-androgen within the last year preceding the study.
- •Patient who underwent orchidectomy or is scheduled to receive an orchidectomy during the course of this study.
Outcomes
Primary Outcomes
Not specified
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