Status:
TERMINATED
Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)
Lead Sponsor:
Ipsen
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone sec...
Eligibility Criteria
Inclusion
- Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy
- Life expectancy of more than 9 months
- Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months
Exclusion
- Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
- Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study
- Concomitant anti-coagulation treatment
- Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study
- Patient with known spinal medullar compression
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00444639
Start Date
February 1 2007
End Date
June 1 2008
Last Update
November 22 2019
Active Locations (15)
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1
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081 HV
2
AMC Amsterdam
Amsterdam, Netherlands, 1105 AZ
3
Alysis Zorggroep Loc. Rijnstate
Arnhem, Netherlands, 6815 AD
4
Maasziekenhuis Pantein
Boxmeer, Netherlands, 5831 HA