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Phase II Multi-Centric, Randomised, Open-label, Parallel-Group 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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase II Multi-Centric, Randomised, Open-label, Parallel-Group 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


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).

Outcome Time Frame:

Week 24

Principal Investigator

Patrick Cabri, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

I-48-52014-142

NCT ID:

NCT00444639

Start Date:

February 2007

Completion Date:

June 2008

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Stress, Psychological

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