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
Phase 2
Completed
- Conditions
- localy advanced prostate cancerprostate cancer10038588
- Registration Number
- NL-OMON29795
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Variables:<br /><br>Percentage of patients achieving a plasma testosterone level * 50 ng/dl (1,7<br /><br>nmol/l) measured at week 24</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Efficacy Variables:<br /><br>Patient acceptability of the injection; the pain experienced during injection,<br /><br>scored by means of a Visual Analogue Scale (VAS), measured at baseline and 12<br /><br>weeks<br /><br>Care giver acceptability of the administration of the injection by means of a<br /><br>Visual Analogue Scale (VAS), at baseline and 12 weeks<br /><br>Percentage of patients achieving a plasma testosterone level * 50 ng/dl (1,7<br /><br>nmol/l) measured at week 12</p><br>